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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06057649
Other study ID # ION UHS
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date January 2024
Est. completion date March 2024

Study information

Verified date November 2023
Source University of Health Sciences Lahore
Contact Aqeela Sarwar, MS Nursing
Phone 03008933826
Email aqeelasarwar@gmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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


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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 52
Est. completion date March 2024
Est. primary completion date March 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years to 25 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Other:
Effleurage Abdominal Massage
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.

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
University of Health Sciences Lahore

Outcome

Type Measure Description Time frame Safety issue
Primary 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.
3 months
Primary 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).
3 months
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