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Comparison of the Effects of Different Massage Techniques in Women With Primary Dysmenorrhea

Primary Purpose

Primary Dysmenorrhea

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Classic massage group
Connective tissue masage
Sponsored by
Ataturk Training and Research Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Primary Dysmenorrhea

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • Over 18 years of age
  • Women with a complaint of primary dysmenorrhea,
  • Volunteer women who have a regular menstrual cycle (28 ± 7 days)
  • Women who have menstrual pain intensity greater than 40 mm according to the Visual Analogue Scale considering the last 6 months

Exclusion Criteria:

  • Having gastrointestinal, urogynecological, autoimmune, psychiatric diseases and/or other chronic pain syndromes,
  • Those who have given birth,
  • Those who have a pregnancy status,
  • Those who use intrauterine devices,
  • Those who have had pelvic surgery,
  • Those who use chronic medications, including oral contraceptives or antidepressants, for at least 6 months before the study,
  • Those with a pathological history and radiological findings showing secondary dysmenorrhea

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Active Comparator

    Arm Label

    Classic massage group

    Connective tissue massage group

    Arm Description

    Classical massage will be applied to the lumbal and abdominal region 5 days a week, from the estimated date of ovulation until the next menstrual bleeding begins. The application will take approximately 15 minutes. During the massage, the physiotherapist will apply stroking and kneading movements by using baby oil. During the treatment of the lumbal region, the patient will be in the prone position; during the treatment of the abdominal region, the patient will be in the supine position.

    Connective tissue massage will be applied to the lumbosacral, lower thoracic, abdominal and anterior pelvic regions 5 days a week, from the estimated date of ovulation until the onset of the next menstrual bleeding. The application will take approximately 15 minutes. During the massage, the physiotherapist will bring the tip of the middle finger of the hand into contact with the patient's skin and apply traction to the skin. During the treatment of the lumbar region, the patient will be in the sitting position, during the treatment of the abdominal and anterior pelvic region, the patient will be in the supine position.

    Outcomes

    Primary Outcome Measures

    Pain intensity
    Menstrual pain intensity will be evaluated with Visual Analogue Scale.

    Secondary Outcome Measures

    Pressure pain threshold
    Pressure pain threshold will be evaluated with algometer
    Primary dysmenorrhea (PD)-related symptoms
    Severity of PD-related symptoms will be evaluated Visual Analogue Scale.
    Functional and emotional effects
    Functional and emotional effects will be evaluated with Functional and Emotional Dysmenorrhea Scale.

    Full Information

    First Posted
    December 2, 2021
    Last Updated
    December 2, 2021
    Sponsor
    Ataturk Training and Research Hospital
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05158036
    Brief Title
    Comparison of the Effects of Different Massage Techniques in Women With Primary Dysmenorrhea
    Official Title
    Comparison of the Effects of Different Massage Techniques in Women With Primary Dysmenorrhea
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    December 2021
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    December 2021 (Anticipated)
    Primary Completion Date
    July 2022 (Anticipated)
    Study Completion Date
    December 2022 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Ataturk Training and Research Hospital

    4. Oversight

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

    5. Study Description

    Brief Summary
    The aim of this study was to compare the effects of different massage techniques on pain, primary dysmenorrhea (PD)-related symptoms and functional and emotional influence in women with PD.
    Detailed Description
    Primary dysmenorrhea is defined as painful menstrual cramps without an underlying pelvic pathology or organic problem. Massage, which is one of the physiotherapy methods that reduces pain by acting on the autonomic nervous system and circulation, has an important place in the management of PD among non-pharmacological treatment approaches. In the literature, there are studies on the use of classical massage and connective tissue massage in women with PD for reducing menstrual pain and PD-related symptoms. However, to the best of our knowledge, no study has been found comparing classical massage and connective tissue massage in PD management.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Primary Dysmenorrhea

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Model Description
    Participants will be randomly divided into two groups
    Masking
    Outcomes Assessor
    Allocation
    Randomized
    Enrollment
    50 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Classic massage group
    Arm Type
    Active Comparator
    Arm Description
    Classical massage will be applied to the lumbal and abdominal region 5 days a week, from the estimated date of ovulation until the next menstrual bleeding begins. The application will take approximately 15 minutes. During the massage, the physiotherapist will apply stroking and kneading movements by using baby oil. During the treatment of the lumbal region, the patient will be in the prone position; during the treatment of the abdominal region, the patient will be in the supine position.
    Arm Title
    Connective tissue massage group
    Arm Type
    Active Comparator
    Arm Description
    Connective tissue massage will be applied to the lumbosacral, lower thoracic, abdominal and anterior pelvic regions 5 days a week, from the estimated date of ovulation until the onset of the next menstrual bleeding. The application will take approximately 15 minutes. During the massage, the physiotherapist will bring the tip of the middle finger of the hand into contact with the patient's skin and apply traction to the skin. During the treatment of the lumbar region, the patient will be in the sitting position, during the treatment of the abdominal and anterior pelvic region, the patient will be in the supine position.
    Intervention Type
    Other
    Intervention Name(s)
    Classic massage group
    Intervention Description
    Classic massage application will be given to the Classic massage group
    Intervention Type
    Other
    Intervention Name(s)
    Connective tissue masage
    Intervention Description
    Connective tissue masage application will be given to the Connective tissue masage group
    Primary Outcome Measure Information:
    Title
    Pain intensity
    Description
    Menstrual pain intensity will be evaluated with Visual Analogue Scale.
    Time Frame
    change from baseline at an average of 2 weeks
    Secondary Outcome Measure Information:
    Title
    Pressure pain threshold
    Description
    Pressure pain threshold will be evaluated with algometer
    Time Frame
    change from baseline at an average of 2 weeks
    Title
    Primary dysmenorrhea (PD)-related symptoms
    Description
    Severity of PD-related symptoms will be evaluated Visual Analogue Scale.
    Time Frame
    change from baseline at an average of 2 weeks
    Title
    Functional and emotional effects
    Description
    Functional and emotional effects will be evaluated with Functional and Emotional Dysmenorrhea Scale.
    Time Frame
    change from baseline at an average of 2 weeks

    10. Eligibility

    Sex
    Female
    Gender Based
    Yes
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Over 18 years of age Women with a complaint of primary dysmenorrhea, Volunteer women who have a regular menstrual cycle (28 ± 7 days) Women who have menstrual pain intensity greater than 40 mm according to the Visual Analogue Scale considering the last 6 months Exclusion Criteria: Having gastrointestinal, urogynecological, autoimmune, psychiatric diseases and/or other chronic pain syndromes, Those who have given birth, Those who have a pregnancy status, Those who use intrauterine devices, Those who have had pelvic surgery, Those who use chronic medications, including oral contraceptives or antidepressants, for at least 6 months before the study, Those with a pathological history and radiological findings showing secondary dysmenorrhea
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Seyda Toprak Celenay
    Phone
    +90312 906 1000
    Email
    sydtoprak@hotmail.com
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Seyda Toprak Celenay
    Organizational Affiliation
    Ankara Yildirim Beyazıt University
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

    Comparison of the Effects of Different Massage Techniques in Women With Primary Dysmenorrhea

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