Premenstrual Syndrome-PMSNCT07526623
Combined Effect of Benson Relaxation Technique and Jacobson Progressive Muscle Relaxation Exercises on Premenstrual Syndrome
A study testing Jacobson progressive muscle relaxation technique, Benson relaxation technique and combine Jacobson progressive muscle relaxation and Benson relaxation technique in people with Premenstrual Syndrome-PMS, run by University of Health Sciences Lahore at 1 site in Pakistan.
Trial summary
Premenstrual syndrome is psycho-physiological stress induced condition including physical, behavioral, and psychological symptoms occur during luteal phase of menstrual cycle (after ovulation) and disappear within a few days after the onset of menstrual cycle .Bloating, breast tenderness, mood swings, food cravings… Read more about this study
- Who is it for?
- Ages 18 to 30 years, women only
- Conditions the study is for
- Premenstrual Syndrome-PMS
- What is being tested?
- Jacobson progressive muscle relaxation technique, Benson relaxation technique and combine Jacobson progressive muscle relaxation and Benson relaxation technique
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 56 participants
- Where
- 1 sitePakistan
- Study dates
- 7 Apr 2026to 21 Jun 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 30 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Age between (18-30 years)
- suffering from PMS
- score of 45 or greater on PMSS
- having regular menstrual cycle between 21- 35 days
- not having a diagnosis of psychiatric problems
- Not having gynecologic disease like abnormal uterine bleeding, ovarian cysts, uterine, fibroids etc.
- Not having any health problem or underlying disease that prevent PMRT.
Who cannot join
- Not using contraceptive pills
- Not attending sessions
- To reduce PMS use another methods
- Withdrawing from the study voluntarily at any stage after inclusion
- Anemia, chronic health conditions, communication related disability
- Any current pharmacologic or non-pharmacologic treatment of PMS
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
University of Health Sciences Lahore
Lahore, Punjab Province, 54000g
About this study
Official title: Combined Effect of Benson Relaxation and Jacobson Progressive Muscle Relaxation Techniques on Premenstrual Syndrome
Premenstrual syndrome is psycho-physiological stress induced condition including physical, behavioral, and psychological symptoms occur during luteal phase of menstrual cycle (after ovulation) and disappear within a few days after the onset of menstrual cycle .Bloating, breast tenderness, mood swings, food cravings, backache, headache, skin breakouts, depression, lack of energy, irritability, frequent urination, and insomnia are the symptoms of premenstrual syndrome. The aim of this study is to determine the combined effect of Benson relaxation and Jacobson progressive muscle relaxation techniques on Premenstrual syndrome. Three-arm parallel Randomized control trial (study design) in which three groups will be formed. A sample size of 56 female students will be selected from University of Health Sciences, Lahore using the purposive sampling technique and will be equally and randomly allocated to three groups using computer generated random number by Excel software. Jacobson PMR technique will be applied on group A and Benson Relaxation Technique on group B and both Benson relaxation and Jacobson progressive muscle relaxation techniques will be applied on group C for two months three times a week. Symptoms will be assessed before and at 8th week (at the end of treatment) by using the Premenstrual Syndrome Scale. There will be assessor blinding while data collecting in order to reduce biasness. The potential significance of combined effect of Benson relaxation technique and Jacobson progressive muscle relaxation is to reduce the symptoms of PMS, improving the quality of life, provide the non-pharmacological approach, improve daily functioning, provide the empowerment to women, enhance relationship, cost - effective, and it is assessable intervention that can be performed in various settings, and will provide the significant positive impact on the lives of women. Combined effect of Benson relaxation and Jacobson progressive muscle relaxation techniques will help in improving symptoms and provide mental and physical relaxation which will help women in enhancing self-control, in reducing absenteeism, improving productivity, increased sense of well- being, and increasing participation in social activities.
Read the detailed description
Premenstrual syndrome is psycho-physiological stress induced condition including physical, behavioral, and psychological symptoms occur during luteal phase of menstrual cycle (after ovulation) and disappear within a few days after the onset of menstrual cycle. Bloating, breast tenderness, mood swings, food cravings, backache, headache, skin breakouts, depression, lack of energy, irritability, frequent urination, and insomnia are the symptoms of premenstrual syndrome. PMS has negative effect on quality of women's life and affect their social life, work-university and family relationships and their leisure activities . Physical activity help in increasing the levels of endorphins, which helps maintain the balance between progesterone and estrogens hormones and also stimulate the anti-inflammatory substances of the body .
Prevalence of PMS in different countries include India (65%), Iran (39.9%), Turkey (52.2%), and global prevalence ranging from (14.3%-74.4%0 and interpretation of PMS include: mild (45%), moderate (32.6%), severe (22.4%) calculated from the King Faisal University in Al Ahsa, Saudi Arabia. Despite the growing knowledge of research on PMS from (2020-2025), there remains a significant gap in literature according to specific intervention that exert their effect. Recent studies (2020-2025) have explored the various interventions and relaxation technique on PMS but there is no study on combined effect of Benson relaxation technique and JPMRT used. In various studies, there is a lack of intervention in control group that may exaggerated the effect of PMRE in experimental group . Further there no blinding of investigator which of might introduce bias in data collection and data analysis. Further there is no follow-up is taken after the application of initial treatment. Blinding procedures in study designs is important because it reduce bias and improve the reliability of results . Use of Combined effect of Benson relaxation technique and PMRT, implication of assessor blinding, and use of conservative treatment in control group in this study will fill the gap in previous studies. Combined effect of Benson relaxation and Jacobson progressive muscle relaxation techniques will help in improving PMS symptoms and provide mental and physical relaxation which will help women in enhancing self -control, improving relationships, in reducing absenteeism, improving productivity, increased sense of well- being, and increasing participation in social activities. The study will help in improving the quality of life, providing the non-pharmacological approach, improve daily functioning , providing the empowerment to women, enhancing relationship ,cost-effective, and it is assessable intervention that can be performed in various settings, and will provide the significant positive impact on the lives of women.
- Conditions
- Premenstrual Syndrome-PMS
- Being tested
- Jacobson progressive muscle relaxation technique, Benson relaxation technique, combine Jacobson progressive muscle relaxation and Benson relaxation technique
- Medical subject headings
- Premenstrual Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Jacobson progressive muscle relaxation techniqueOther
Jacobson PMR involves gradually contracting and relaxing the major 16 muscle group of human body from head to toe ( muscle include hands, arms, eye, eyebrows, neck, anterior neck, shoulder, back, chest, abdomen, buttocks, anterior thigh, posterior thigh, calves and feet)
Benson relaxation techniqueOther
Benson Relaxation technique was presents in 1970 by Herbert Benson. Benson Relaxation technique decrease the level of hormone catecholamine and also reduces the sympathetic nervous system which results in relaxation of muscle and also reducing anxiety and depression level in our body which results in promoting activities of daily life and build self- confidence.
combine Jacobson progressive muscle relaxation and Benson relaxation techniqueOther
Jacobson PMR involves gradually contracting and relaxing the major 16 muscle group of human body from head to toe ( muscle include hands, arms, eye, eyebrows, neck, anterior neck, shoulder, back, chest, abdomen, buttocks, anterior thigh, posterior thigh, calves and feet). In Benson relaxation technique, participants will be placed in comfortable positions and will be asked to close their eyes and will focus on their breathing to remove disturbing thoughts from their mind and they will be asked to remind a word that bring peace to them such as God, love, rainbow etc. While repeating the sedative words breathe deeply and regularly, inhale through nose and exhale through mouth. At the same time they will be asked to relax their whole body muscle starting from tip of toes and continuing their upper body and the head muscles. They will be asked not to think about any other thing and continue this exercise for 20 minutes and then open their eyes
| Study group | Role | What they receive |
|---|---|---|
| Treatment 1 | Experimental | Jacobson progressive Muscle Relaxation Tecnique Receives: Other: Jacobson progressive muscle relaxation technique |
| Treatment 2 | Experimental | Benson relaxation Technique Receives: Other: Benson relaxation technique |
| Combine Treatment | Experimental | Combination of Jacobson progressive Muscle relaxation and Benson relaxation technique Receives: Other: combine Jacobson progressive muscle relaxation and Benson relaxation technique |
What is being measured
The primary outcome is the main question the study is designed to answer.
Premenstrual Syndrome Scale
Premenstrual Syndrome scale is a self-reporting scale was originally developed by comprise of 40 questions which is further divide into 3 subscales (Physiological, Psychological, and Behavioral symptoms). Ms. Padmavathi measured the inter-rater reliability of PMSS in 2013. In interrater reliability was reported between 0.81 and 0.97 and sensitivity ranges from 83-100% and specificity 64-90%.
Measured: From enrollment to the end of treatment at 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2026
- Study start7 Apr 2026
- Primary completion7 Jun 2026 (estimated)
- Study completion21 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Premenstrual Syndrome-PMSStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Health Sciences Lahore
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ayesha Abdul Hameed, University of Health Sciences Lahore
- Investigators
- University of Health Sciences Lahore Lahore, Principal investigator, University of Health Sciences Lahore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07526623
- Sponsor's protocol ID
- UHS/USERC-26/SEC/103
- Status last verified
- Apr 2026
- First submitted
- 6 Apr 2026
- Last updated
- 13 Apr 2026
- 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 13 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Combined Effect of Benson Relaxation and Jacobson Progressive Muscle Relaxation Techniques on Premenstrual Syndrome
- ClinicalTrials.gov ID
- NCT07526623
- Acronym / sponsor ID
- UHS/USERC-26/SEC/103
- Conditions
- Premenstrual Syndrome-PMS
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 56 participants (actual)
- Lead sponsor
- University of Health Sciences LahoreUniversity, hospital or other
- Study start
- 7 Apr 2026 (actual)
- Primary completion
- 7 Jun 2026 (estimated)
- Study completion
- 21 Jun 2026 (estimated)
- First posted
- 13 Apr 2026 (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.
Premenstrual syndrome is psycho-physiological stress induced condition including physical, behavioral, and psychological symptoms occur during luteal phase of menstrual cycle (after ovulation) and disappear within a few days after the onset of menstrual cycle .Bloating, breast tenderness, mood swings, food cravings, backache, headache, skin breakouts, depression, lack of energy, irritability, frequent urination, and insomnia are the symptoms of premenstrual syndrome. The aim of this study is to determine the combined effect of Benson relaxation and Jacobson progressive muscle relaxation techniques on Premenstrual syndrome. Three-arm parallel Randomized control trial (study design) in which three groups will be formed. A sample size of 56 female students will be selected from University of Health Sciences, Lahore using the purposive sampling technique and will be equally and randomly allocated to three groups using computer generated random number by Excel software. Jacobson PMR technique will be applied on group A and Benson Relaxation Technique on group B and both Benson relaxation and Jacobson progressive muscle relaxation techniques will be applied on group C for two months three times a week. Symptoms will be assessed before and at 8th week (at the end of treatment) by using the Premenstrual Syndrome Scale. There will be assessor blinding while data collecting in order to reduce biasness. The potential significance of combined effect of Benson relaxation technique and Jacobson progressive muscle relaxation is to reduce the symptoms of PMS, improving the quality of life, provide the non-pharmacological approach, improve daily functioning, provide the empowerment to women, enhance relationship, cost - effective, and it is assessable intervention that can be performed in various settings, and will provide the significant positive impact on the lives of women. Combined effect of Benson relaxation and Jacobson progressive muscle relaxation techniques will help in improving symptoms and provide mental and physical relaxation which will help women in enhancing self-control, in reducing absenteeism, improving productivity, increased sense of well- being, and increasing participation in social activities.
Detailed description
Premenstrual syndrome is psycho-physiological stress induced condition including physical, behavioral, and psychological symptoms occur during luteal phase of menstrual cycle (after ovulation) and disappear within a few days after the onset of menstrual cycle. Bloating, breast tenderness, mood swings, food cravings, backache, headache, skin breakouts, depression, lack of energy, irritability, frequent urination, and insomnia are the symptoms of premenstrual syndrome. PMS has negative effect on quality of women's life and affect their social life, work-university and family relationships and their leisure activities . Physical activity help in increasing the levels of endorphins, which helps maintain the balance between progesterone and estrogens hormones and also stimulate the anti-inflammatory substances of the body .
Prevalence of PMS in different countries include India (65%), Iran (39.9%), Turkey (52.2%), and global prevalence ranging from (14.3%-74.4%0 and interpretation of PMS include: mild (45%), moderate (32.6%), severe (22.4%) calculated from the King Faisal University in Al Ahsa, Saudi Arabia. Despite the growing knowledge of research on PMS from (2020-2025), there remains a significant gap in literature according to specific intervention that exert their effect. Recent studies (2020-2025) have explored the various interventions and relaxation technique on PMS but there is no study on combined effect of Benson relaxation technique and JPMRT used. In various studies, there is a lack of intervention in control group that may exaggerated the effect of PMRE in experimental group . Further there no blinding of investigator which of might introduce bias in data collection and data analysis. Further there is no follow-up is taken after the application of initial treatment. Blinding procedures in study designs is important because it reduce bias and improve the reliability of results . Use of Combined effect of Benson relaxation technique and PMRT, implication of assessor blinding, and use of conservative treatment in control group in this study will fill the gap in previous studies. Combined effect of Benson relaxation and Jacobson progressive muscle relaxation techniques will help in improving PMS symptoms and provide mental and physical relaxation which will help women in enhancing self -control, improving relationships, in reducing absenteeism, improving productivity, increased sense of well- being, and increasing participation in social activities. The study will help in improving the quality of life, providing the non-pharmacological approach, improve daily functioning , providing the empowerment to women, enhancing relationship ,cost-effective, and it is assessable intervention that can be performed in various settings, and will provide the significant positive impact on the lives of women.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Treatment 1 | Experimental | Other: Jacobson progressive muscle relaxation techniqueJacobson progressive Muscle Relaxation Tecnique |
| Treatment 2 | Experimental | Other: Benson relaxation techniqueBenson relaxation Technique |
| Combine Treatment | Experimental | Other: combine Jacobson progressive muscle relaxation and Benson relaxation techniqueCombination of Jacobson progressive Muscle relaxation and Benson relaxation technique |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Age between (18-30 years)
- suffering from PMS
- score of 45 or greater on PMSS
- having regular menstrual cycle between 21- 35 days
- not having a diagnosis of psychiatric problems
Key exclusion criteria (6 listed)
- Not using contraceptive pills
- Not attending sessions
- To reduce PMS use another methods
- Withdrawing from the study voluntarily at any stage after inclusion
- Anemia, chronic health conditions, communication related disability
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 |
|---|---|---|
| Jacobson progressive muscle relaxation techniqueJacobson PMR involves gradually contracting and relaxing the major 16 muscle group of human body from head to toe ( muscle include hands, arms, eye, eyebrows, neck, anterior neck, shoulder, back, chest, abdomen, buttocks, anterior thigh, posterior thigh, calves and feet) | Other | Treatment 1 |
| Benson relaxation techniqueBenson Relaxation technique was presents in 1970 by Herbert Benson. Benson Relaxation technique decrease the level of hormone catecholamine and also reduces the sympathetic nervous system which results in relaxation of muscle and also reducing anxiety and depression level in our body which results in promoting activities of daily life and build self- confidence. | Other | Treatment 2 |
| combine Jacobson progressive muscle relaxation and Benson relaxation techniqueJacobson PMR involves gradually contracting and relaxing the major 16 muscle group of human body from head to toe ( muscle include hands, arms, eye, eyebrows, neck, anterior neck, shoulder, back, chest, abdomen, buttocks, anterior thigh, posterior thigh, calves and feet). In Benson relaxation technique, participants will be placed in comfortable positions and will be asked to close their eyes and will focus on their breathing to remove disturbing thoughts from their mind and they will be asked to remind a word that bring peace to them such as God, love, rainbow etc. While repeating the sedative words breathe deeply and regularly, inhale through nose and exhale through mouth. At the same time they will be asked to relax their whole body muscle starting from tip of toes and continuing their upper body and the head muscles. They will be asked not to think about any other thing and continue this exercise for 20 minutes and then open their eyes | Other | Combine Treatment |
Primary outcome
Premenstrual Syndrome Scale
Time frame: From enrollment to the end of treatment at 8 weeks
Premenstrual Syndrome scale is a self-reporting scale was originally developed by comprise of 40 questions which is further divide into 3 subscales (Physiological, Psychological, and Behavioral symptoms). Ms. Padmavathi measured the inter-rater reliability of PMSS in 2013. In interrater reliability was reported between 0.81 and 0.97 and sensitivity ranges from 83-100% and specificity 64-90%.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2026.
- 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.
University of Health Sciences Lahore Lahore principal investigator
University of Health Sciences Lahore
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Jacobson progressive muscle relaxation technique, Benson relaxation technique and combine Jacobson progressive muscle relaxation and Benson relaxation technique in people with Premenstrual Syndrome-PMS, 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 7 inclusion and 6 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: under way, not looking for participants, as of the sponsor's last update on 13 Apr 2026. 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?
This study is still under way. Results are not available in the source record yet.
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?
Premenstrual Syndrome Scale (time frame: From enrollment to the end of treatment at 8 weeks). 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 13 Apr 2026.