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The Effect of Abdominal Massage and Exercise on Primary Dysmenorrhea in University Students

Primary Purpose

Primary Dysmenorrhea

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
The exercise group
The abdominal massage group
Control Group
Sponsored by
Aydin Adnan Menderes University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Primary Dysmenorrhea focused on measuring Abdominal massage, Exercise, Primary Dysmenorrhea

Eligibility Criteria

18 Years - 20 Years (Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

Regular menstrual cycles Record ≥ 6 points on VAS in the first 3 days of at least 2 of the last 3 menstrual cycles Not use analgesics during the study period

Exclusion Criteria:

Endometriosis Pelvic inflammatory disease Ovarian cyst Myoma Chronic pelvic pain Urinary system infection Menometrorrhagia Obstructive vaginal or uterine congenital anomalies Secondary dysmenorrhea A history of major abdominal or pelvic surgery in the last 3 months Hormonal treatment in the last 6 months.

Sites / Locations

  • Meryem Kurek Eken

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Placebo Comparator

Arm Label

The exercise group

The abdominal massage group

The control group

Arm Description

The group will be instructed to perform stretching exercises including the pelvic and lumbar regions 3 times a day for the first 3 days of the menstrual cycle

The group will be instructed to massage the abdomen for 10 mins a day on the first 3 days of the menstrual cycle.The massage is to be applied as effleurage (light touch) clockwise over the abdomen

The control group will perform no exercise or massage.

Outcomes

Primary Outcome Measures

The primer outcome of the study was to investigate the effects of abdominal massage and exercise on the level of pain
Visuale Analogue Scale will be used to measure pain level at 3 menstrual cycle. The change from baseline in Visual Analog Scale at 3 menstrual cycle will be measured in the studied groups
The other primer outcome of the study was to investigate the effects of abdominal massage and exercise duration of pain.
Dysmenorrhea Symptom List will be used to measure degree of dysmenorrhea symptoms at 3 menstrual cycle. The findings seen in the presence of dysmenorrhea in females during 3 menstrual cycle will be measured by decrease at severity of scores belong to Dysmenorrhea Symptom List.

Secondary Outcome Measures

The seconder outcome of the study was to investigate the effects of abdominal massage and exercise amount of menstruel bleeding
Pictorial Blood Loss Evaluation Table will be used to measure the amount of menstrual bleeding. The amount of menstrual bleeding will be measured by change from baseline in the pictorial index score at 3 menstrual cycle

Full Information

First Posted
December 30, 2018
Last Updated
July 3, 2019
Sponsor
Aydin Adnan Menderes University
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1. Study Identification

Unique Protocol Identification Number
NCT03821207
Brief Title
The Effect of Abdominal Massage and Exercise on Primary Dysmenorrhea in University Students
Official Title
The Effect of Abdominal Massage and Exercise on Primary Dysmenorrhea in University Students: A Randomised Controlled Study
Study Type
Interventional

2. Study Status

Record Verification Date
July 2019
Overall Recruitment Status
Completed
Study Start Date
December 6, 2018 (Actual)
Primary Completion Date
June 6, 2019 (Actual)
Study Completion Date
July 2, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Aydin Adnan Menderes 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 study will planing to determine the advantages of abdominal massage and exercise on primary dysmenorrhea in university students, and to evaluate whether one of these applications is superior to the other.
Detailed Description
The students included in the study will be randomly separated into 3 groups using a computer-based randomisation plan (www.randomization.com). Those included in the massage group will be instructed to massage the abdomen for 10 mins a day on the first 3 days of the menstrual cycle. The massage is to be applied as effleurage (light touch) clockwise over the abdomen from over the abdominal wall to the intestinal area. The students in the exercise group will be instructed to perform stretching exercises including the pelvic and lumbar regions 3 times a day for the first 3 days of the menstrual cycle. The control group will perform no exercise or massage. The applications will be demonstrated to the participants by a physiotherapist. Throughout the study period, the students will be followed up to ensure that the applications are being made. Follow-up of the applications of abdominal massage and stretching exercises applied by there searcher physiotherapist according to the study plan will be conducted by the researchers. The participants will be informed how to apply the massage and perform the exercises and that these applications will cause no side-effects. They will also be informed that participation in the study is voluntary and they can withdraw from the study at any time. The study will include volunteer female students, aged 18- 20 years, with regular menstrual cycles, who record ≥ 6 points on VAS in the first 3 days of at least 2 of the last 3 menstrual cycles and will not use analgesics during the study. Data Collection Tools Personal Information Form: This form was prepared by the researchers in accordance with previous reports in literature to include 5 socio-demographic items and 14 items related to the menstrual history (age of menarche, frequency of painful menstruation, amount of bleeding, family history of painful menstruation, methods of dealing with the pain, etc). Visual Analog Scale (VAS):This scale is a simple method used in the measurement of pain severity and in the follow-up of pain. The patient is instructed to mark the severity of pain on a 10cm horizontal line, where 0= non pain and 10= intolerable pain. Dysmenorrhea Symptom List:This list was prepared by the researchers in accordance with literature to evaluate the efficacy of the application and includes the findings seen in the presence of dysmenorrhea in females. Each finding is scored from 0-3 as 0= non symptom, 1= mild symptom that does not affect daily activity, 2 = mild non-debilitating symptom that affects daily activity, 3= totally debilitating severe symptom. Amount of Menstrual Blood: As it is impossible to measure blood lost during menstruation in a laboratory environment, a pictorial blood loss evaluation table will be used,which is a practical and low-cost method with a high accuracy rate. The pictorial blood loss evaluation table was developed to show the degree of soiling. The participants will be given detailed instructions of how to use these forms and will be checked as to whether or not they have understood by being instructed to record a bleeding pattern described by the researchers (eg, mark on the table that in the first 2 days you have used 5 pads completely soiled and in the following 3 days, 2 half pads and 1 with staining). The pictorial index score is calculated by giving points of 1, 5 and 20 to mild, moderately and heavily soiled pads respectively, and scores of 1 and 5 for small and large clots. A cut-off value of 100 will be used. To reduce misinterpretations resulting from the use of different pads, all the participants will be recommended to use the same brand of sanitary pad.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Primary Dysmenorrhea
Keywords
Abdominal massage, Exercise, Primary Dysmenorrhea

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Model Description
Randomised Controlled Study
Masking
None (Open Label)
Allocation
Randomized
Enrollment
22 (Actual)

8. Arms, Groups, and Interventions

Arm Title
The exercise group
Arm Type
Active Comparator
Arm Description
The group will be instructed to perform stretching exercises including the pelvic and lumbar regions 3 times a day for the first 3 days of the menstrual cycle
Arm Title
The abdominal massage group
Arm Type
Active Comparator
Arm Description
The group will be instructed to massage the abdomen for 10 mins a day on the first 3 days of the menstrual cycle.The massage is to be applied as effleurage (light touch) clockwise over the abdomen
Arm Title
The control group
Arm Type
Placebo Comparator
Arm Description
The control group will perform no exercise or massage.
Intervention Type
Behavioral
Intervention Name(s)
The exercise group
Intervention Description
The students will make exercise during the first three days of the menstrual period
Intervention Type
Behavioral
Intervention Name(s)
The abdominal massage group
Intervention Description
The students will make abdominal massage during the first three days of the menstrual period
Intervention Type
Behavioral
Intervention Name(s)
Control Group
Intervention Description
The students will nor massage or exercise
Primary Outcome Measure Information:
Title
The primer outcome of the study was to investigate the effects of abdominal massage and exercise on the level of pain
Description
Visuale Analogue Scale will be used to measure pain level at 3 menstrual cycle. The change from baseline in Visual Analog Scale at 3 menstrual cycle will be measured in the studied groups
Time Frame
6 month
Title
The other primer outcome of the study was to investigate the effects of abdominal massage and exercise duration of pain.
Description
Dysmenorrhea Symptom List will be used to measure degree of dysmenorrhea symptoms at 3 menstrual cycle. The findings seen in the presence of dysmenorrhea in females during 3 menstrual cycle will be measured by decrease at severity of scores belong to Dysmenorrhea Symptom List.
Time Frame
6 month
Secondary Outcome Measure Information:
Title
The seconder outcome of the study was to investigate the effects of abdominal massage and exercise amount of menstruel bleeding
Description
Pictorial Blood Loss Evaluation Table will be used to measure the amount of menstrual bleeding. The amount of menstrual bleeding will be measured by change from baseline in the pictorial index score at 3 menstrual cycle
Time Frame
6 month

10. Eligibility

Sex
Female
Gender Based
Yes
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Regular menstrual cycles Record ≥ 6 points on VAS in the first 3 days of at least 2 of the last 3 menstrual cycles Not use analgesics during the study period Exclusion Criteria: Endometriosis Pelvic inflammatory disease Ovarian cyst Myoma Chronic pelvic pain Urinary system infection Menometrorrhagia Obstructive vaginal or uterine congenital anomalies Secondary dysmenorrhea A history of major abdominal or pelvic surgery in the last 3 months Hormonal treatment in the last 6 months.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Meryem Kurek Eken
Organizational Affiliation
Aydin Adnan Menderes University
Official's Role
Study Director
Facility Information:
Facility Name
Meryem Kurek Eken
City
Aydın
ZIP/Postal Code
09013
Country
Turkey

12. IPD Sharing Statement

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The Effect of Abdominal Massage and Exercise on Primary Dysmenorrhea in University Students

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