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Effects of Effleurage Abdominal Massage on Pain and Quality of Life in Primary Dysmenorrhea Among Students in Lahore

Primary Purpose

Primary Dysmenorrhea

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Effleurage Abdominal Massage
Sponsored by
University of Health Sciences Lahore
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Primary Dysmenorrhea focused on measuring primary dysmenorrhea, Female university students, Pain, Quality of Life

Eligibility Criteria

18 Years - 25 Years (Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria: Unmarried female university students from Lahore Aged between 18-25 years Diagnosed patients by gynecologist with primary dysmenorrhea for three previous consecutive cycles. Regular menstrual cycles ranging 21-35 days lasting for 3-7 days. Having pain score of 6 or more than 6 on Numeric Pain Rating Scale Exclusion Criteria: Presence of any known abdominal or pelvic disease. Obstructive vaginal or uterine congenital anomalies. Presence of known or suspected secondary dysmenorrhea. History of major abdominal or pelvic surgery in the previous three months. History of hormonal therapy in the last six months. History of using analgesics during menstruation. History of having any medical disease i.e. cardiac and renal disease. Participants doing regular exercise.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    No Intervention

    Experimental

    Arm Label

    control

    experimental

    Arm Description

    participants of control group will receive no intervention. they will be instructed to continue with their routine practices

    Participants of experimental group will perform effleurage abdominal massage

    Outcomes

    Primary Outcome Measures

    Measurement of Dysmenorrhea Induced Pain intensity
    Outcome Measurement Tool: Numeric Pain Rating Scale: Dysmenorrhea induced pain intensity measured by Numerical pain rating scale will be used having numbers from 0 to 10 to indicate the intensity of pain. Here is a breakdown of the numeric rating pain scale 0: No pain. 1-3: Mild pain. 4-6: Moderate pain. 7-9: Severe pain. 10: Excruciating pain.
    Measure the level of Quality of Life
    Outcome Measurement Tool: Euroqol-5D-5L scale for Quality of Life: The EQ-5D-5L scale will be used to assess students' quality of life across five dimensions and will allow respondents to indicate their level of functioning or health in each dimension with 1 as highest and 5 as lowest for each dimension. Additionally, EQ-5D-5L includes a visual analog scale (VAS) that will allow respondents to rate their overall health on a scale from 0 (worst imaginable health) to 100 (best imaginable health).

    Secondary Outcome Measures

    Full Information

    First Posted
    September 19, 2023
    Last Updated
    September 26, 2023
    Sponsor
    University of Health Sciences Lahore
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    1. Study Identification

    Unique Protocol Identification Number
    NCT06057649
    Brief Title
    Effects of Effleurage Abdominal Massage on Pain and Quality of Life in Primary Dysmenorrhea Among Students in Lahore
    Official Title
    Effects of Effleurage Abdominal Massage on Pain and Quality of Life in Primary Dysmenorrhea Among Female University Students in Lahore
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    September 2023 (Anticipated)
    Primary Completion Date
    March 2024 (Anticipated)
    Study Completion Date
    March 1, 2024 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    University of Health Sciences Lahore

    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
    To find out the answer of the study question that effleurage abdominal massage has any effect on pain and quality of life in primary dysmenorrhea among university students or nota study will be conducted with an objective to evaluate the effects of effleurage abdominal massage on pain and quality of life in primary dysmenorrhea among university students
    Detailed Description
    Primary dysmenorrhea, the commonly occurring gynecological issue faced by young girls. It severely affects quality of female life. It leads to fatigue, psychological issues, lack of interest in selfcare and daily activities that results in absenteeism at work and educational institutes. It also badly affects academic performance and extra-curricular activities. Different pharmacological and non-pharmacological interventions are being used for reducing its negative effects, such as effleurage abdominal massage intend to decrease the problems faced by students as a result of this frightening issue. Here the question arises for health professionals that effleurage abdominal massage has any effect on pain and quality of life in primary dysmenorrhea among university students or not? To find out the answer of this question a study will be conducted with an objective to evaluate the effects of effleurage abdominal massage on pain and quality of life in primary dysmenorrhea among university students. This study holds considerable implications in addressing potential adverse effects associated with pharmacological analgesic agents, thereby mitigating pain, lack of interest in work and enhancing functional capacity, hence improving quality of life. Moreover, it is anticipated to contribute to the reduction of healthcare costs.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Primary Dysmenorrhea
    Keywords
    primary dysmenorrhea, Female university students, Pain, Quality of Life

    7. Study Design

    Primary Purpose
    Supportive Care
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Model Description
    Participants will be randomly allocated to control and experimental group. participants in control group will continue with their routine care and experimental group will receive effleurage abdominal massage alongwith routine practices
    Masking
    Outcomes Assessor
    Masking Description
    a third person will be involved as second assessor for blinding
    Allocation
    Randomized
    Enrollment
    52 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    control
    Arm Type
    No Intervention
    Arm Description
    participants of control group will receive no intervention. they will be instructed to continue with their routine practices
    Arm Title
    experimental
    Arm Type
    Experimental
    Arm Description
    Participants of experimental group will perform effleurage abdominal massage
    Intervention Type
    Other
    Intervention Name(s)
    Effleurage Abdominal Massage
    Intervention Description
    perform the effleurage massage by following these steps: Lie in supine position with knee slightly flexed. Start from the right lower quadrant, using gentle pressure, rub in tiny clockwise circular motions using any non-analgesic cream, towards right rib cage then towards upper left side, moving down the left side to hip bone. Keep up the circular massage while moving inward, toward your belly button for three minutes. After three minutes, use a little more pressure, continuing the circular movements for 10 minutes. Massage for 10 minutes a day for two months during the first 3 days of the menstrual cycle.
    Primary Outcome Measure Information:
    Title
    Measurement of Dysmenorrhea Induced Pain intensity
    Description
    Outcome Measurement Tool: Numeric Pain Rating Scale: Dysmenorrhea induced pain intensity measured by Numerical pain rating scale will be used having numbers from 0 to 10 to indicate the intensity of pain. Here is a breakdown of the numeric rating pain scale 0: No pain. 1-3: Mild pain. 4-6: Moderate pain. 7-9: Severe pain. 10: Excruciating pain.
    Time Frame
    3 months
    Title
    Measure the level of Quality of Life
    Description
    Outcome Measurement Tool: Euroqol-5D-5L scale for Quality of Life: The EQ-5D-5L scale will be used to assess students' quality of life across five dimensions and will allow respondents to indicate their level of functioning or health in each dimension with 1 as highest and 5 as lowest for each dimension. Additionally, EQ-5D-5L includes a visual analog scale (VAS) that will allow respondents to rate their overall health on a scale from 0 (worst imaginable health) to 100 (best imaginable health).
    Time Frame
    3 months

    10. Eligibility

    Sex
    Female
    Gender Based
    Yes
    Gender Eligibility Description
    primary dysmenorrhea belongs to female gender
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    25 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Unmarried female university students from Lahore Aged between 18-25 years Diagnosed patients by gynecologist with primary dysmenorrhea for three previous consecutive cycles. Regular menstrual cycles ranging 21-35 days lasting for 3-7 days. Having pain score of 6 or more than 6 on Numeric Pain Rating Scale Exclusion Criteria: Presence of any known abdominal or pelvic disease. Obstructive vaginal or uterine congenital anomalies. Presence of known or suspected secondary dysmenorrhea. History of major abdominal or pelvic surgery in the previous three months. History of hormonal therapy in the last six months. History of using analgesics during menstruation. History of having any medical disease i.e. cardiac and renal disease. Participants doing regular exercise.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Aqeela Sarwar, MS Nursing
    Phone
    03008933826
    Email
    aqeelasarwar@gmail.com
    First Name & Middle Initial & Last Name or Official Title & Degree
    Muhammad Faisal, Bachelors
    Phone
    03247677687
    Email
    faisalarien66@gmail.com
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Aqeela Sarwar, MS Nursing
    Organizational Affiliation
    PG Nursing
    Official's Role
    Study Chair

    12. IPD Sharing Statement

    Plan to Share IPD
    No

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    Effects of Effleurage Abdominal Massage on Pain and Quality of Life in Primary Dysmenorrhea Among Students in Lahore

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