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The Effects Of Relaxation Training In Women With Primary Dysmenorrhea

Primary Purpose

Primary Dysmenorrhea

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Relaxation training
No intervention
Sponsored by
Ankara Yildirim Beyazıt University
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:

  • Women with primary dysmenorrhea complaint according to the Primary Dysmenorrhea Consensus Guide,
  • Over 18 years of age,
  • Having a mean pain intensity of moderate and higher according to the Visual Analogue Scale in the last 6 months,
  • Having a regular menstrual cycle (28±7 days),
  • Volunteered to participate in the study.

Exclusion Criteria:

  • Having a pathological history and radiological findings pointing to secondary dysmenorrhea,
  • Using oral contraceptives/antidepressants at least 6 months,
  • Receiving hormone therapy,
  • Undergoing pelvic surgery,
  • Pregnant,
  • Giving birth,
  • Using an intrauterine device,
  • Having neurological, orthopedic and/or rheumatological diseases
  • Having a psychiatric disease,
  • Having a history of malignancy

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Other

    Arm Label

    Relaxation group

    Control group

    Arm Description

    Jacobson progressive relaxation training will be applied

    No intervention will be applied

    Outcomes

    Primary Outcome Measures

    Menstrual pain intensity
    Menstrual pain intensity will be evaluated with Visual Analogue Scale. This scale consists of a 10 cm horizontal line. The starting point "0" = "no pain", while "10" = "unbearable pain". Individuals will be asked to mark on a 10 cm straight line according to the level of pain they feel. Pain intensity will be recorded by measuring the distance between the beginning of the line and the marked place.

    Secondary Outcome Measures

    Menstrual symptoms
    Menstrual symptoms will be measured with the menstrual symptom questionnaire. Menstrual Symptom Questionnaire is a 24-item self-report scale and each item is scored between 1 (never) and 5 (always). An increase in the mean score indicates an increase in the severity of menstrual symptoms. The total score is 120 points.
    Impacts of academic/work performance
    Impacts of academic/work performance will be evaluated with Visual Analogue Scale. This scale consists of a 10 cm horizontal line. The starting point "0"= means "my work/school performance is not affected in any way", while "10"= means "my work/school performance is greatly affected"
    Impacts of life quality
    Impacts of life quality will be evaluated with Visual Analogue Scale. This scale consists of a 10 cm horizontal line. The starting point "0" = "my quality of life is not affected in any way", while "10" = "my quality of life is greatly affected". Individuals will be asked to mark on a 10 cm straight line according to the quality of life they think.
    Impacts of social activity
    Impacts of social activity will be evaluated with Visual Analogue Scale. This scale consists of a 10 cm horizontal line. The starting point "0" = "my social activity is not affected in any way", while "10" = "my social activity is greatly affected". Individuals will be asked to mark on a 10 cm straight line according to the social activity they think.
    Anxiety level
    Anxiety level will be assessed with the Spielberger State Trait Anxiety Inventory. This inventory is a 40-item self-report inventory designed to measure both state anxiety section (current feelings of apprehension, worry, etc.) and trait anxiety section (continuous feelings of apprehension, worry, etc.). Each section is scored on four levels of anxiety intensity from 1="not at all" to 4="very much" and with a sum score between 20 and 80. A higher total score indicates more severe anxiety level.

    Full Information

    First Posted
    April 7, 2022
    Last Updated
    April 7, 2022
    Sponsor
    Ankara Yildirim Beyazıt University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05328869
    Brief Title
    The Effects Of Relaxation Training In Women With Primary Dysmenorrhea
    Official Title
    The Effects Of Relaxation Training In Women With Primary Dysmenorrhea
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    April 2022
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    May 15, 2022 (Anticipated)
    Primary Completion Date
    October 15, 2022 (Anticipated)
    Study Completion Date
    December 15, 2022 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Ankara Yildirim Beyazıt University

    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 investigate the effects of relaxation training on menstrual pain severity, menstrual symptoms, impact of quality of life, impact of work/academic performance, impact of social activity level and anxiety level in women with primary dysmenorrhea (PD) complaints.
    Detailed Description
    PD is the cramping pain that comes before or during a menstrual period. Relaxation training contributes to the reduction of stress and pain. Thus, there is a need to investigate the effects of relaxation training in dysmenorrhea.

    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
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    30 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Relaxation group
    Arm Type
    Experimental
    Arm Description
    Jacobson progressive relaxation training will be applied
    Arm Title
    Control group
    Arm Type
    Other
    Arm Description
    No intervention will be applied
    Intervention Type
    Other
    Intervention Name(s)
    Relaxation training
    Intervention Description
    Relaxation training will be performed under the supervision of a physiotherapist. The training is carried out from the estimated day of ovulation (cycle length in days minus 14) until the next menstrual period begins
    Intervention Type
    Other
    Intervention Name(s)
    No intervention
    Intervention Description
    No intervention will be applied. The natural process will be followed from the estimated day of ovulation (cycle length in days minus 14) until the next menstrual period begins
    Primary Outcome Measure Information:
    Title
    Menstrual pain intensity
    Description
    Menstrual pain intensity will be evaluated with Visual Analogue Scale. This scale consists of a 10 cm horizontal line. The starting point "0" = "no pain", while "10" = "unbearable pain". Individuals will be asked to mark on a 10 cm straight line according to the level of pain they feel. Pain intensity will be recorded by measuring the distance between the beginning of the line and the marked place.
    Time Frame
    change from baseline at an average of 2 weeks
    Secondary Outcome Measure Information:
    Title
    Menstrual symptoms
    Description
    Menstrual symptoms will be measured with the menstrual symptom questionnaire. Menstrual Symptom Questionnaire is a 24-item self-report scale and each item is scored between 1 (never) and 5 (always). An increase in the mean score indicates an increase in the severity of menstrual symptoms. The total score is 120 points.
    Time Frame
    change from baseline at an average of 2 weeks
    Title
    Impacts of academic/work performance
    Description
    Impacts of academic/work performance will be evaluated with Visual Analogue Scale. This scale consists of a 10 cm horizontal line. The starting point "0"= means "my work/school performance is not affected in any way", while "10"= means "my work/school performance is greatly affected"
    Time Frame
    change from baseline at an average of 2 weeks
    Title
    Impacts of life quality
    Description
    Impacts of life quality will be evaluated with Visual Analogue Scale. This scale consists of a 10 cm horizontal line. The starting point "0" = "my quality of life is not affected in any way", while "10" = "my quality of life is greatly affected". Individuals will be asked to mark on a 10 cm straight line according to the quality of life they think.
    Time Frame
    change from baseline at an average of 2 weeks
    Title
    Impacts of social activity
    Description
    Impacts of social activity will be evaluated with Visual Analogue Scale. This scale consists of a 10 cm horizontal line. The starting point "0" = "my social activity is not affected in any way", while "10" = "my social activity is greatly affected". Individuals will be asked to mark on a 10 cm straight line according to the social activity they think.
    Time Frame
    change from baseline at an average of 2 weeks
    Title
    Anxiety level
    Description
    Anxiety level will be assessed with the Spielberger State Trait Anxiety Inventory. This inventory is a 40-item self-report inventory designed to measure both state anxiety section (current feelings of apprehension, worry, etc.) and trait anxiety section (continuous feelings of apprehension, worry, etc.). Each section is scored on four levels of anxiety intensity from 1="not at all" to 4="very much" and with a sum score between 20 and 80. A higher total score indicates more severe anxiety level.
    Time Frame
    change from baseline at an average of 2 weeks

    10. Eligibility

    Sex
    Female
    Gender Based
    Yes
    Gender Eligibility Description
    Primary dysmenorrhea is a gynecological problem that can be seen in most women.
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Women with primary dysmenorrhea complaint according to the Primary Dysmenorrhea Consensus Guide, Over 18 years of age, Having a mean pain intensity of moderate and higher according to the Visual Analogue Scale in the last 6 months, Having a regular menstrual cycle (28±7 days), Volunteered to participate in the study. Exclusion Criteria: Having a pathological history and radiological findings pointing to secondary dysmenorrhea, Using oral contraceptives/antidepressants at least 6 months, Receiving hormone therapy, Undergoing pelvic surgery, Pregnant, Giving birth, Using an intrauterine device, Having neurological, orthopedic and/or rheumatological diseases Having a psychiatric disease, Having a history of malignancy
    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

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