Primary DysmenorrheaNCT06057649
Effects of Effleurage Abdominal Massage on Pain and Quality of Life in Primary Dysmenorrhea Among Students in Lahore
A study testing Effleurage Abdominal Massage in people with Primary Dysmenorrhea, run by University of Health Sciences Lahore at 1 site in Pakistan.
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… Read more about this study
- Who is it for?
- Ages 18 to 25 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Primary Dysmenorrhea
- What is being tested?
- Effleurage Abdominal Massage
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 1 sitePakistan
- Study dates
- 8 Apr 2024to 1 Nov 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 25 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Effleurage Abdominal Massage on Pain and Quality of Life in Primary Dysmenorrhea Among Female University Students in Lahore
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
Read the 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.
- Conditions
- Primary Dysmenorrhea
- Being tested
- Effleurage Abdominal Massage
- Keywords
- primary dysmenorrhea, Female university students, Pain, Quality of Life
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Effleurage Abdominal MassageOther
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.
| Study group | Role | What they receive |
|---|---|---|
| control | No intervention | participants of control group will receive no intervention. they will be instructed to continue with their routine practices |
| experimental | Experimental | Participants of experimental group will perform effleurage abdominal massage Receives: Other: Effleurage Abdominal Massage |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3 months
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).
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2023
- Study start8 Apr 2024
- Primary completion30 Jul 2024
- Study completion1 Nov 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Primary DysmenorrheaStudies of the same condition, open and under way.
- More trials run by University of Health Sciences LahoreThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Health Sciences Lahore
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Aqeela Sarwar, University of Health Sciences Lahore
- Investigators
- Aqeela Sarwar, MS Nursing, Study chair, PG Nursing
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06057649
- Sponsor's protocol ID
- ION UHS
- Status last verified
- Jan 2025
- First submitted
- 19 Sep 2023
- Last updated
- 22 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Effleurage Abdominal Massage on Pain and Quality of Life in Primary Dysmenorrhea Among Female University Students in Lahore
- ClinicalTrials.gov ID
- NCT06057649
- Acronym / sponsor ID
- ION UHS
- Conditions
- Primary Dysmenorrhea
- Keywords
- primary dysmenorrhea, Female university students, Pain, Quality of Life
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- University of Health Sciences LahoreUniversity, hospital or other
- Study start
- 8 Apr 2024 (actual)
- Primary completion
- 30 Jul 2024 (actual)
- Study completion
- 1 Nov 2024 (actual)
- First posted
- 28 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- 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
| Arm | Type | Receives |
|---|---|---|
| control | No intervention | –participants of control group will receive no intervention. they will be instructed to continue with their routine practices |
| experimental | Experimental | Other: Effleurage Abdominal MassageParticipants of experimental group will perform effleurage abdominal massage |
Who may qualify
- Ages
- 18 to 25 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Effleurage Abdominal Massageperform 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. | Other | experimental |
Primary outcome
Measurement of Dysmenorrhea Induced Pain intensity
Time frame: 3 months
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
Time frame: 3 months
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).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jan 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Aqeela Sarwar, MS Nursing study chair
PG Nursing
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Effleurage Abdominal Massage in people with Primary Dysmenorrhea, run by University of Health Sciences Lahore at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Measurement of Dysmenorrhea Induced Pain intensity (time frame: 3 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jan 2025.