- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06057649
Effects of Effleurage Abdominal Massage on Pain and Quality of Life in Primary Dysmenorrhea Among Students in Lahore
Effects of Effleurage Abdominal Massage on Pain and Quality of Life in Primary Dysmenorrhea Among Female University Students in Lahore
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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-
Punjab
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Lahore, Punjab, Pakistan, 1122
- College of Nursing AIMC
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
No Intervention: control
participants of control group will receive no intervention.
they will be instructed to continue with their routine practices
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|
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Experimental: experimental
Participants of experimental group will perform effleurage abdominal massage
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Measurement of Dysmenorrhea Induced Pain intensity
Time Frame: 3 months
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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
|
3 months
|
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Measure the level of Quality of Life
Time Frame: 3 months
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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). |
3 months
|
Collaborators and Investigators
Investigators
- Study Chair: Aqeela Sarwar, MS Nursing, PG Nursing
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- ION UHS
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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