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The Effect of Connective Tissue Manipulation on General Health and Emotional Status in Women With Primary Dysmenorrhea

Primary Purpose

Primary Dysmenorrhea

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Connective Tissue Manipulation
Sponsored by
Istanbul University - Cerrahpasa (IUC)
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Primary Dysmenorrhea focused on measuring primary dysmenorrhea, pain, women, connective tissue manipulation, longterm follow up

Eligibility Criteria

18 Years - 30 Years (Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • Being in a age range 18-30
  • Diagnosed with Primary Dysmenorrhea by a gynecologist
  • Having a regular menstrual cycle (28±7 days)
  • Being nulliparous
  • Having menstrual pain intensity above 5cm according to Visual Analog Scale

Exclusion Criteria:

  • Having gastrointestinal, urogynecologic, or psychiatric disease, other chronic pain syndromes
  • Having a positive pregnancy test
  • History of pelvic surgery
  • Usage of oral contraceptives or antidepressants for at least 3 months
  • Having irregular menstrual cycles (defined as lasting<21or>35 days)
  • Having a history or an ultrasonographic observation of pathological conditions indicating secondary dysmenorrhea

Sites / Locations

  • Pamukkale University

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Group 1

Group 2

Arm Description

Connective Tissue Manipulation was performed to participants in Group 1, starting at the end of the menstrual cycle, 5 days a week and for 1 cycle (approximately 3 weeks) until the beginning of the next period.

In Group 2, Connective Tissue Manipulation was started with the completion of menstrual cycle performed to participants for 5 days a week and until the other menstrual cycles. At the end of the menstrual cycle, it was restarted and a total of 2 cycles were applied until the second menstrual cycle started (approximately 6 weeks).

Outcomes

Primary Outcome Measures

Visual Analogue Scale
Intensity of menstrual pain was evaluated by a 0- to 10-cm Visual Analog Scale (VAS), where "0" point indicated "no pain" and "10" indicated "unbearable pain."
Visual Analogue Scale
Intensity of menstrual pain was evaluated by a 0- to 10-cm Visual Analog Scale (VAS), where "0" point indicated "no pain" and "10" indicated "unbearable pain."
Visual Analogue Scale
Intensity of menstrual pain was evaluated by a 0- to 10-cm Visual Analog Scale (VAS), where "0" point indicated "no pain" and "10" indicated "unbearable pain."
Visual Analogue Scale
Intensity of menstrual pain was evaluated by a 0- to 10-cm Visual Analog Scale (VAS), where "0" point indicated "no pain" and "10" indicated "unbearable pain."

Secondary Outcome Measures

Visual Analogue Scale
Intensity of sleep disturbance was evaluated by a 0- to 10-cm Visual Analog Scale (VAS), where "0" point indicated "no sleep disturbance" and "10" indicated "unbearable disturbance."
Visual Analogue Scale
Intensity of sleep disturbance was evaluated by a 0- to 10-cm Visual Analog Scale (VAS), where "0" point indicated "no sleep disturbance" and "10" indicated "unbearable disturbance."
Visual Analogue Scale
Intensity of sleep disturbance was evaluated by a 0- to 10-cm Visual Analog Scale (VAS), where "0" point indicated "no sleep disturbance" and "10" indicated "unbearable disturbance."
Visual Analogue Scale
Intensity of sleep disturbance was evaluated by a 0- to 10-cm Visual Analog Scale (VAS), where "0" point indicated "no sleep disturbance" and "10" indicated "unbearable disturbance."
Visual Analogue Scale
Fatigue status of the participants during dysmenorrhea was evaluated using a 10 cm VAS. Participants were asked to mark the severity of the fatigue they felt on the 10 cm line, which wrote an unbearable fatigue on one end and the other end no fatigue.
Visual Analogue Scale
Fatigue status of the participants during dysmenorrhea was evaluated using a 10 cm VAS. Participants were asked to mark the severity of the fatigue they felt on the 10 cm line, which wrote an unbearable fatigue on one end and the other end no fatigue.
Visual Analogue Scale
Fatigue status of the participants during dysmenorrhea was evaluated using a 10 cm VAS. Participants were asked to mark the severity of the fatigue they felt on the 10 cm line, which wrote an unbearable fatigue on one end and the other end no fatigue.
Visual Analogue Scale
Fatigue status of the participants during dysmenorrhea was evaluated using a 10 cm VAS. Participants were asked to mark the severity of the fatigue they felt on the 10 cm line, which wrote an unbearable fatigue on one end and the other end no fatigue.
Beck Depression Inventory
Beck Depression Inventory which is self-administrated questionnaire was used to determine depressive symptoms during the menstrual periods of the participants. The inventory includes 21 questions and is scored by adding the scores of each question, which are scored between 0 and 3. Lower scores indicate less depressive symptoms, while higher scores show more depressive symptoms
Beck Depression Inventory
Beck Depression Inventory which is self-administrated questionnaire was used to determine depressive symptoms during the menstrual periods of the participants. The inventory includes 21 questions and is scored by adding the scores of each question, which are scored between 0 and 3. Lower scores indicate less depressive symptoms, while higher scores show more depressive symptoms
Beck Depression Inventory
Beck Depression Inventory which is self-administrated questionnaire was used to determine depressive symptoms during the menstrual periods of the participants. The inventory includes 21 questions and is scored by adding the scores of each question, which are scored between 0 and 3. Lower scores indicate less depressive symptoms, while higher scores show more depressive symptoms
Beck Depression Inventory
Beck Depression Inventory which is self-administrated questionnaire was used to determine depressive symptoms during the menstrual periods of the participants. The inventory includes 21 questions and is scored by adding the scores of each question, which are scored between 0 and 3. Lower scores indicate less depressive symptoms, while higher scores show more depressive symptoms
Beck Anxiety Inventory
Anxiety experienced by participants during menstrual periods was measured using Beck Anxiety Inventory (BAI). Each item is rated on a 4-point scale reflecting the degree to which each symptom disturbs participants; the answer options range from 0 (not at all) to 3 (severely, I could barely stand it). With higher scores indicating more severe anxiety.
Beck Anxiety Inventory
Anxiety experienced by participants during menstrual periods was measured using Beck Anxiety Inventory (BAI). Each item is rated on a 4-point scale reflecting the degree to which each symptom disturbs participants; the answer options range from 0 (not at all) to 3 (severely, I could barely stand it). With higher scores indicating more severe anxiety.
Beck Anxiety Inventory
Anxiety experienced by participants during menstrual periods was measured using Beck Anxiety Inventory (BAI). Each item is rated on a 4-point scale reflecting the degree to which each symptom disturbs participants; the answer options range from 0 (not at all) to 3 (severely, I could barely stand it). With higher scores indicating more severe anxiety.
Beck Anxiety Inventory
Anxiety experienced by participants during menstrual periods was measured using Beck Anxiety Inventory (BAI). Each item is rated on a 4-point scale reflecting the degree to which each symptom disturbs participants; the answer options range from 0 (not at all) to 3 (severely, I could barely stand it). With higher scores indicating more severe anxiety.
General Health Questionnaire
General Health Questionnaire was used to determine the health status of the participants during their menstrual periods. A 28 item scaled version-assesses somatic symptoms, anxiety, and insomnia, social dysfunction and severe depression. Likert's numbering method (as 0, 1, 2, and 3) was utilized. It means that scores higher than 6 in subscales and totally higher than 22 indicates chronic symptoms.
General Health Questionnaire
General Health Questionnaire was used to determine the health status of the participants during their menstrual periods. A 28 item scaled version-assesses somatic symptoms, anxiety, and insomnia, social dysfunction and severe depression. Likert's numbering method (as 0, 1, 2, and 3) was utilized. It means that scores higher than 6 in subscales and totally higher than 22 indicates chronic symptoms.
General Health Questionnaire
General Health Questionnaire was used to determine the health status of the participants during their menstrual periods. A 28 item scaled version-assesses somatic symptoms, anxiety, and insomnia, social dysfunction and severe depression. Likert's numbering method (as 0, 1, 2, and 3) was utilized. It means that scores higher than 6 in subscales and totally higher than 22 indicates chronic symptoms.
General Health Questionnaire
General Health Questionnaire was used to determine the health status of the participants during their menstrual periods. A 28 item scaled version-assesses somatic symptoms, anxiety, and insomnia, social dysfunction and severe depression. Likert's numbering method (as 0, 1, 2, and 3) was utilized. It means that scores higher than 6 in subscales and totally higher than 22 indicates chronic symptoms.
Premenstrual Syndrome Scale
Premenstrual Syndrome Scale was used to measure the severity of the participants' premenstrual symptoms. The lowest possible total score is 44 points and the highest is 220. High PMSS score indicates more severe premenstrual symptoms.
Premenstrual Syndrome Scale
Premenstrual Syndrome Scale was used to measure the severity of the participants' premenstrual symptoms. The lowest possible total score is 44 points and the highest is 220. High PMSS score indicates more severe premenstrual symptoms.
Premenstrual Syndrome Scale
Premenstrual Syndrome Scale was used to measure the severity of the participants' premenstrual symptoms. The lowest possible total score is 44 points and the highest is 220. High PMSS score indicates more severe premenstrual symptoms.
Premenstrual Syndrome Scale
Premenstrual Syndrome Scale was used to measure the severity of the participants' premenstrual symptoms. The lowest possible total score is 44 points and the highest is 220. High PMSS score indicates more severe premenstrual symptoms.

Full Information

First Posted
July 14, 2020
Last Updated
August 11, 2020
Sponsor
Istanbul University - Cerrahpasa (IUC)
Collaborators
Pamukkale University
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1. Study Identification

Unique Protocol Identification Number
NCT04509934
Brief Title
The Effect of Connective Tissue Manipulation on General Health and Emotional Status in Women With Primary Dysmenorrhea
Official Title
The Effect of Connective Tissue Manipulation on General Health and Emotional Status in Women With Primary Dysmenorrhea: Long-Term Follow-Up
Study Type
Interventional

2. Study Status

Record Verification Date
August 2020
Overall Recruitment Status
Completed
Study Start Date
July 30, 2018 (Actual)
Primary Completion Date
March 30, 2020 (Actual)
Study Completion Date
March 30, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Istanbul University - Cerrahpasa (IUC)
Collaborators
Pamukkale University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this study was to reveal the effects of connective tissue manipulation (CTM) on pain severity, fatigue, sleep quality, general health status, systemic symptoms, anxiety and depression in women with primary dysmenorrhoea and to determine the effect of treatment time on recovery in a longterm period. Our primary outcome was intensity of menstrual pain. Secondary outcomes were intensity of sleep disturbance, fatigue, depression and anxiety status, general health and premenstrual symptoms.
Detailed Description
The purpose of this study was to reveal the effects of CTM on pain severity, fatigue, sleep quality, general health status, systemic symptoms, anxiety and depression in women with primary dysmenorrhoea and to determine the effect of treatment time on recovery in a longterm period. Our primary outcome was intensity of menstrual pain. Secondary outcomes were intensity of sleep disturbance, fatigue, depression and anxiety status, general health and premenstrual symptoms. The participants included to this study were randomised into two groups with simple randomisation method. CTM was performed to participants in both groups included the basic region (Sacral and lumbar), lower thoracic (between T12-T7) and anterior pelvic regions. In Group 1, starting at the end of the menstrual cycle, CTM was applied for 5 days a week and for 1 cycle (approximately 3 weeks) until the beginning of the next period. Participants in the Group 2 CTM was started with the completion of menstrual cycle, 5 days a week and until the other menstrual cycles. At the end of the menstrual cycle, it was restarted and a total of 2 cycles were applied until the second menstrual cycle started (approximately 6 weeks). Both short and long strokes were used during manipulation. Each stroke was repeated for three times first on the right and then on the left side of all manipulated regions. All sessions were ended with bilateral long strokes to the iliac crest and subcostal regions. The treatment was started from the basic region and proceeded to other regions according to the vascular reaction of the connective tissue. Each session lasted 5 to 20 minutes, depending on the size of the treated region. During manipulation, the pad of the middle finger was in contact with the patient's skin. The finger was placed on the skin at 45° angle with distal interphalangeal joint in flexion and moved to cause traction. During back treatment, the participant was asked to sit erect, with hips, knees, and ankles at 90° flexion and thighs and feet are fully supported. During the treatment of anterior pelvic region, the patient was in a supine position with pillows placed under the head and knees. Treatment was performed by a trained physiotherapist. The participants' intensity of pain, fatigue and sleep quality were assessed with Visual Analogue Scale. Depressive symptoms and anxiety status, general health and premenstrual symptoms were assessed with Beck Depression Inventory, Beck Anxiety Inventory, General Health Questionnaire and Premenstrual Syndrome Scale, respectively. All measurements were repeated 5 times; baseline, after the first menstruation following the intervention period, 3th, 6th and 12th months after treatment.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Primary Dysmenorrhea
Keywords
primary dysmenorrhea, pain, women, connective tissue manipulation, longterm follow up

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Masking Description
The statistical analyses will be performed by the statistics specialist that does not know anything about the methodology of the study.
Allocation
Randomized
Enrollment
39 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group 1
Arm Type
Active Comparator
Arm Description
Connective Tissue Manipulation was performed to participants in Group 1, starting at the end of the menstrual cycle, 5 days a week and for 1 cycle (approximately 3 weeks) until the beginning of the next period.
Arm Title
Group 2
Arm Type
Active Comparator
Arm Description
In Group 2, Connective Tissue Manipulation was started with the completion of menstrual cycle performed to participants for 5 days a week and until the other menstrual cycles. At the end of the menstrual cycle, it was restarted and a total of 2 cycles were applied until the second menstrual cycle started (approximately 6 weeks).
Intervention Type
Other
Intervention Name(s)
Connective Tissue Manipulation
Intervention Description
The position of the patients during treatment sessions was sitting with the hips and knees at 90° flexion and feet supported, arms relaxed on the thighs, back naked and straight, allowing optimal tension of the connective tissue. The CTM procedure consisted of treating 3 sections in the back. These sections were basic (sacral and lumbar regions), lower thoracic (L1 through T7) and anterior pelvic. All sessions were ended with bilateral long strokes to the iliac crest and subcostal regions. The physiotherapist applied strokes bilaterally by her middle finger of the right or left hand to the defined zones of the mentioned sections in the back. The treatment started from the basic section, and progress to other regions was decided according to the vascular reaction of the connective tissue. Each session lasted for 5 to 20 minutes, depending on the extent of the treated area.
Primary Outcome Measure Information:
Title
Visual Analogue Scale
Description
Intensity of menstrual pain was evaluated by a 0- to 10-cm Visual Analog Scale (VAS), where "0" point indicated "no pain" and "10" indicated "unbearable pain."
Time Frame
baseline (first assessment) and 3th, 6th and 12th months after treatment
Title
Visual Analogue Scale
Description
Intensity of menstrual pain was evaluated by a 0- to 10-cm Visual Analog Scale (VAS), where "0" point indicated "no pain" and "10" indicated "unbearable pain."
Time Frame
3th month after treatment
Title
Visual Analogue Scale
Description
Intensity of menstrual pain was evaluated by a 0- to 10-cm Visual Analog Scale (VAS), where "0" point indicated "no pain" and "10" indicated "unbearable pain."
Time Frame
6th month after treatment
Title
Visual Analogue Scale
Description
Intensity of menstrual pain was evaluated by a 0- to 10-cm Visual Analog Scale (VAS), where "0" point indicated "no pain" and "10" indicated "unbearable pain."
Time Frame
12th month after treatment
Secondary Outcome Measure Information:
Title
Visual Analogue Scale
Description
Intensity of sleep disturbance was evaluated by a 0- to 10-cm Visual Analog Scale (VAS), where "0" point indicated "no sleep disturbance" and "10" indicated "unbearable disturbance."
Time Frame
baseline (first assessment)
Title
Visual Analogue Scale
Description
Intensity of sleep disturbance was evaluated by a 0- to 10-cm Visual Analog Scale (VAS), where "0" point indicated "no sleep disturbance" and "10" indicated "unbearable disturbance."
Time Frame
3th month after treatment
Title
Visual Analogue Scale
Description
Intensity of sleep disturbance was evaluated by a 0- to 10-cm Visual Analog Scale (VAS), where "0" point indicated "no sleep disturbance" and "10" indicated "unbearable disturbance."
Time Frame
6th month after treatment
Title
Visual Analogue Scale
Description
Intensity of sleep disturbance was evaluated by a 0- to 10-cm Visual Analog Scale (VAS), where "0" point indicated "no sleep disturbance" and "10" indicated "unbearable disturbance."
Time Frame
12th month after treatment
Title
Visual Analogue Scale
Description
Fatigue status of the participants during dysmenorrhea was evaluated using a 10 cm VAS. Participants were asked to mark the severity of the fatigue they felt on the 10 cm line, which wrote an unbearable fatigue on one end and the other end no fatigue.
Time Frame
baseline (first assessment)
Title
Visual Analogue Scale
Description
Fatigue status of the participants during dysmenorrhea was evaluated using a 10 cm VAS. Participants were asked to mark the severity of the fatigue they felt on the 10 cm line, which wrote an unbearable fatigue on one end and the other end no fatigue.
Time Frame
3th month after treatment
Title
Visual Analogue Scale
Description
Fatigue status of the participants during dysmenorrhea was evaluated using a 10 cm VAS. Participants were asked to mark the severity of the fatigue they felt on the 10 cm line, which wrote an unbearable fatigue on one end and the other end no fatigue.
Time Frame
6th month after treatment
Title
Visual Analogue Scale
Description
Fatigue status of the participants during dysmenorrhea was evaluated using a 10 cm VAS. Participants were asked to mark the severity of the fatigue they felt on the 10 cm line, which wrote an unbearable fatigue on one end and the other end no fatigue.
Time Frame
12th month after treatment
Title
Beck Depression Inventory
Description
Beck Depression Inventory which is self-administrated questionnaire was used to determine depressive symptoms during the menstrual periods of the participants. The inventory includes 21 questions and is scored by adding the scores of each question, which are scored between 0 and 3. Lower scores indicate less depressive symptoms, while higher scores show more depressive symptoms
Time Frame
baseline (first assessment)
Title
Beck Depression Inventory
Description
Beck Depression Inventory which is self-administrated questionnaire was used to determine depressive symptoms during the menstrual periods of the participants. The inventory includes 21 questions and is scored by adding the scores of each question, which are scored between 0 and 3. Lower scores indicate less depressive symptoms, while higher scores show more depressive symptoms
Time Frame
3th month after treatment
Title
Beck Depression Inventory
Description
Beck Depression Inventory which is self-administrated questionnaire was used to determine depressive symptoms during the menstrual periods of the participants. The inventory includes 21 questions and is scored by adding the scores of each question, which are scored between 0 and 3. Lower scores indicate less depressive symptoms, while higher scores show more depressive symptoms
Time Frame
6th month after treatment
Title
Beck Depression Inventory
Description
Beck Depression Inventory which is self-administrated questionnaire was used to determine depressive symptoms during the menstrual periods of the participants. The inventory includes 21 questions and is scored by adding the scores of each question, which are scored between 0 and 3. Lower scores indicate less depressive symptoms, while higher scores show more depressive symptoms
Time Frame
12th month after treatment
Title
Beck Anxiety Inventory
Description
Anxiety experienced by participants during menstrual periods was measured using Beck Anxiety Inventory (BAI). Each item is rated on a 4-point scale reflecting the degree to which each symptom disturbs participants; the answer options range from 0 (not at all) to 3 (severely, I could barely stand it). With higher scores indicating more severe anxiety.
Time Frame
baseline (first assessment)
Title
Beck Anxiety Inventory
Description
Anxiety experienced by participants during menstrual periods was measured using Beck Anxiety Inventory (BAI). Each item is rated on a 4-point scale reflecting the degree to which each symptom disturbs participants; the answer options range from 0 (not at all) to 3 (severely, I could barely stand it). With higher scores indicating more severe anxiety.
Time Frame
3th month after treatment
Title
Beck Anxiety Inventory
Description
Anxiety experienced by participants during menstrual periods was measured using Beck Anxiety Inventory (BAI). Each item is rated on a 4-point scale reflecting the degree to which each symptom disturbs participants; the answer options range from 0 (not at all) to 3 (severely, I could barely stand it). With higher scores indicating more severe anxiety.
Time Frame
6th month after treatment
Title
Beck Anxiety Inventory
Description
Anxiety experienced by participants during menstrual periods was measured using Beck Anxiety Inventory (BAI). Each item is rated on a 4-point scale reflecting the degree to which each symptom disturbs participants; the answer options range from 0 (not at all) to 3 (severely, I could barely stand it). With higher scores indicating more severe anxiety.
Time Frame
12th month after treatment
Title
General Health Questionnaire
Description
General Health Questionnaire was used to determine the health status of the participants during their menstrual periods. A 28 item scaled version-assesses somatic symptoms, anxiety, and insomnia, social dysfunction and severe depression. Likert's numbering method (as 0, 1, 2, and 3) was utilized. It means that scores higher than 6 in subscales and totally higher than 22 indicates chronic symptoms.
Time Frame
baseline (first assessment)
Title
General Health Questionnaire
Description
General Health Questionnaire was used to determine the health status of the participants during their menstrual periods. A 28 item scaled version-assesses somatic symptoms, anxiety, and insomnia, social dysfunction and severe depression. Likert's numbering method (as 0, 1, 2, and 3) was utilized. It means that scores higher than 6 in subscales and totally higher than 22 indicates chronic symptoms.
Time Frame
3th month after treatment
Title
General Health Questionnaire
Description
General Health Questionnaire was used to determine the health status of the participants during their menstrual periods. A 28 item scaled version-assesses somatic symptoms, anxiety, and insomnia, social dysfunction and severe depression. Likert's numbering method (as 0, 1, 2, and 3) was utilized. It means that scores higher than 6 in subscales and totally higher than 22 indicates chronic symptoms.
Time Frame
6th month after treatment
Title
General Health Questionnaire
Description
General Health Questionnaire was used to determine the health status of the participants during their menstrual periods. A 28 item scaled version-assesses somatic symptoms, anxiety, and insomnia, social dysfunction and severe depression. Likert's numbering method (as 0, 1, 2, and 3) was utilized. It means that scores higher than 6 in subscales and totally higher than 22 indicates chronic symptoms.
Time Frame
12th month after treatment
Title
Premenstrual Syndrome Scale
Description
Premenstrual Syndrome Scale was used to measure the severity of the participants' premenstrual symptoms. The lowest possible total score is 44 points and the highest is 220. High PMSS score indicates more severe premenstrual symptoms.
Time Frame
baseline (first assessment)
Title
Premenstrual Syndrome Scale
Description
Premenstrual Syndrome Scale was used to measure the severity of the participants' premenstrual symptoms. The lowest possible total score is 44 points and the highest is 220. High PMSS score indicates more severe premenstrual symptoms.
Time Frame
3th month after treatment
Title
Premenstrual Syndrome Scale
Description
Premenstrual Syndrome Scale was used to measure the severity of the participants' premenstrual symptoms. The lowest possible total score is 44 points and the highest is 220. High PMSS score indicates more severe premenstrual symptoms.
Time Frame
6th month after treatment
Title
Premenstrual Syndrome Scale
Description
Premenstrual Syndrome Scale was used to measure the severity of the participants' premenstrual symptoms. The lowest possible total score is 44 points and the highest is 220. High PMSS score indicates more severe premenstrual symptoms.
Time Frame
12th month after treatment

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
30 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Being in a age range 18-30 Diagnosed with Primary Dysmenorrhea by a gynecologist Having a regular menstrual cycle (28±7 days) Being nulliparous Having menstrual pain intensity above 5cm according to Visual Analog Scale Exclusion Criteria: Having gastrointestinal, urogynecologic, or psychiatric disease, other chronic pain syndromes Having a positive pregnancy test History of pelvic surgery Usage of oral contraceptives or antidepressants for at least 3 months Having irregular menstrual cycles (defined as lasting<21or>35 days) Having a history or an ultrasonographic observation of pathological conditions indicating secondary dysmenorrhea
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nesrin Yağcı, PT, Prof
Organizational Affiliation
Pamukkale University
Official's Role
Study Chair
Facility Information:
Facility Name
Pamukkale University
City
Denizli
ZIP/Postal Code
20000
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No

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The Effect of Connective Tissue Manipulation on General Health and Emotional Status in Women With Primary Dysmenorrhea

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