StressNCT06028360
Progressive Muscle Relaxation (PMR) in Stress Management Among Physiotherapy Students
A study testing Progressive Muscle Relaxation and Virtual Reality Therapy in people with Stress, run by Shalamar Institute of Health Sciences at 1 site in Pakistan.
Trial summary
The objective of this clinical trial is to observe the effect of Virtual Reality (VR) and Progressive muscle relaxation (PMR) in stressed individuals. Procedure: Students will be invited verbally and procedure will be explained to them. 20 students will be recruited randomly into control and experimental group. Read more about this study
- Who is it for?
- Ages 18 to 24 yearsHealthy volunteers can take part
- Conditions the study is for
- Stress
- What is being tested?
- Progressive Muscle Relaxation and Virtual Reality Therapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Oct 2023to 31 Dec 2023
- 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 24 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Students of either sex, aged between 18-24 years
- Students with Stress (through perceived stress scale PSS, any individual with a score above 14)
Who cannot join
- Students more susceptible to motion sickness (Through VIMSSQ),
- Students with in-corrected eye-sight,
- Students with phobias relevant to landscapes/views of mountains, forests, beaches and night-skies.
Trial locations and contacts
1 site in 1 country.
Pakistan1 site, 1 recruiting
- Recruiting
Shalamar Medical and Dental College
Lahore, Punjab Province, 46994
Dr. Masooma Gull, MSc, masoomagull2@ymail.com
Reema Khanam, DPT
About this study
Official title: The Effect of Virtual Reality (VR) and Progressive Muscle Relaxation (PMR) in Stress Management Among Physiotherapy Students
The objective of this clinical trial is to observe the effect of Virtual Reality (VR) and Progressive muscle relaxation (PMR) in stressed individuals.
Procedure:
Students will be invited verbally and procedure will be explained to them. 20 students will be recruited randomly into control and experimental group. Stress will be predicted using multiple questionnaires. Pss is given before and after the intervention. The students in control group will be given 10 mins session of PMR for 3 consecutive days and in intervention group will be given 10 mins session of PMR followed by 8 mins session of VR for 3 consecutive days in which specific landscapes i.e mountains, forests, nightskies and beaches.
Read the detailed description
Introduction:
As stress appears to be a natural human response to difficult situations prompting us to address challenges and threats in our lives, prolonged stress may cause the fight or flight response to over-ride body's normal physiology and produce multiple psychological and physiological symptoms resulting in various negative health conditions such as cardiovascular disorders, GIT disturbances, hypertension etc. Moreover, a global survey of adolescents in 72 countries found 66% of students reported feeling stressed about academics and 37% of students felt anxiety relating to schoolwork. Many stress reduction interventions such as Progressive Muscular Relaxation (PMR), mindfulness meditation, deep breathing exercises, and guided imagery have been shown to reduce stress levels among individuals and are being used as traditional relaxation interventions.
Progressive muscle relaxation (PMR) originally known as Jacobson Muscle Relaxation Technique, was developed by Edmund Jacobson in the 1934. It is an actively engaging technique guiding the patients to consciously contract muscles to create tension and release it progressively. This is repeated until patients acquire complete relaxation. Many studies on PMR have proven it to be beneficial in decreasing stress and anxiety levels in many adults as well as children worldwide.
With emerging technology, innovative ideas, such as the use of VR (Virtual Reality) for stress management, have also been considered and studied. According to Cruz-Neira (1993), Virtual reality refers to immersive, interactive, multisensory, viewer-centered, 3D computer generated environments and the combination of technologies required building environments. In the healthcare sector, VR has been proved beneficial for balance and cognition training in cerebral palsy and stroke, and also has been observed to mitigate acute and chronic pain. It can provide rehabilitation, motivation and entertainment all at once. Further studies on its immersive effect suggest it to be helpful in stress management. Natural environments (forests, beaches, mountains etc ) viewed through VR, have shown to help individuals reduce their stress levels, anxiety disorders, and phobias. However, there is little research on individual preferences of different VR landscapes.
In Asia, research relevant to VR has been shown to have a positive effect on stress management in individuals with high stress and mood disorders. Effect of forest and water landscapes on stress management has also been discussed earlier. However, area for more research still remains.
In Pakistan, multiple researches have been conducted on the use of VR in health care and as a rehabilitative intervention for diseases such as stroke, parkinsons, cerebral palsy and amblyopia, but very limited evidence is available on the effect of VR on stress management. No such research has been conducted in this region or in our institution prior to our study.
A study conducted in India showed that the PSS score decreased from mean 22.2 to 16.5 while another study conducted in India indicated that PMR and talk therapy in college students, reduced percieved stress from PSS score of 32.30 to 23.03.
The purpose of our research is to investigate the effect of VR in stress management, the individual preferences of landscapes and its comparison with traditional relaxation technique such as Progressive Muscle Relaxation (PMR). This will help health-care workers improve stress management in a technology driven community.
Statistical analysis:
data will be entered and analyzed using SPSS 25. Numerical data like age, PSS score will be presented in the form of mean ± S.D whereas qualitative data like gender, Pre/Post intervention stress etc. will be presented in the form of Frequency (Percentage). After fulfilling parametric assumptions, Repeated measure ANOVA will be applied.
Potential benefits:
- The subjects receiving the interventions will experience reduced stress and anxiety.
- The subjects will be introduced to an innovative and immersive technology i.e., VR.
- A step will be taken forward towards the use of technology in stress management, along with a traditional relaxation technique such as Progressive muscle relaxation (PMR).
- The use of VR for stress management is cost effective and time saving.
Potential risks:
- Motion Sickness It will be tried to minimize by excluding the susceptible subjects, using Visually Induced Motion Sickness Susceptibility Questionnaire (VIMSSQ). Also subjects with any psychological or in-corrected eye sight will not be included in the study. In case the above mentioned risk develops during the intervention, the subject will be given rest.
- Increased Drop Out Rate If the required sample size is not met due to high drop out rate, new participants will be recruited and the procedure will be repeated until required amount of data is available.
- Conditions
- Stress
- Being tested
- Progressive Muscle Relaxation, Virtual Reality Therapy
- Keywords
- Psychological stress, progressive muscle relaxation (PMR)
- Medical subject headings
- Stress, Psychological
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Progressive Muscle RelaxationOther
Also called PMR
Intervention will be applied for 15-20 minutes 3 consecutive days a week for 1 week
Virtual Reality TherapyDevice
Also called VR Therapy
Therapy through VR will be given for 8 minutes 3 times a week on consecutively for 1 week
| Study group | Role | What they receive |
|---|---|---|
| Progressive Muscle Relaxation | Active comparator | Progressive muscle relaxation will be applied for 15-20 minutes for 3 consecutive days for 1 week. Receives: Other: Progressive Muscle Relaxation |
| Virtual Reality | Experimental | Virtual reality session will be given for 8 mins for 3 consecutive days for 1 week. Receives: Other: Progressive Muscle Relaxation; Device: Virtual Reality Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Stress Reduction
Reduction in Perceived Stress scale(PSS) from the previous reading will be considered as stress reduction. information will be collected before and after the treatment on each day. The scoring of Perceived Stress scale(PSS) ranges between 0-40, where 0-13 means low stress, 14-26 means moderate stress and 27-40 would be considered as high perceived stress
Measured: the outcome will be determine at the base line of the treatment and at the 3rd day after initiation oftreatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2023
- Study start1 Oct 2023 (estimated)
- Primary completion10 Nov 2023 (estimated)
- Study completion31 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for StressStudies of the same condition, open and under way.
- 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
- Model description
- A Randomized Control Trial with a Control and an Experimental group that will be given intervention 3 consecutive days.
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shalamar Institute of Health Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Reema Khanam, DPT, Principal investigator, Shalamar Medical and Dental CollegeLaiba Khan, DPT, Principal investigator, Shalamar Medical and Dental CollegeMaha Sohail, DPT, Principal investigator, Shalamar Medical and Dental College
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06028360
- Sponsor's protocol ID
- SSAHS 2023/02
- Status last verified
- Sep 2023
- First submitted
- 31 Aug 2023
- Last updated
- 28 Sep 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Gao T, Zhang T, Zhu L, Gao Y, Qiu L. Exploring Psychophysiological Restoration and Individual Preference in the Different Environments Based on Virtual Reality. Int J Environ Res Public Health. 2019 Aug 26;16(17):3102. doi: 10.3390/ijerph16173102.
PubMed 31455015Wang X, Shi Y, Zhang B, Chiang Y. The Influence of Forest Resting Environments on Stress Using Virtual Reality. Int J Environ Res Public Health. 2019 Sep 5;16(18):3263. doi: 10.3390/ijerph16183263.
PubMed 31491931Allison S, Irwin Hamilton K, Yuan Y, Wallis Hague G. Assessment of Progressive Muscle Relaxation (PMR) as a Stress-Reducing Technique for First-Year Veterinary Students. J Vet Med Educ. 2020 Dec;47(6):737-744. doi: 10.3138/jvme.2018-0013. Epub 2019 Nov 15.
PubMed 31738679Ruotolo I, Berardi A, Sellitto G, Panuccio F, Polimeni A, Valente D, Galeoto G. Criterion Validity and Reliability of SF-12 Health Survey Version 2 (SF-12v2) in a Student Population during COVID-19 Pandemic: A Cross-Sectional Study. Depress Res Treat. 2021 Aug 4;2021:6624378. doi: 10.1155/2021/6624378. eCollection 2021.
PubMed 34394986Levenstein S, Prantera C, Varvo V, Scribano ML, Berto E, Luzi C, Andreoli A. Development of the Perceived Stress Questionnaire: a new tool for psychosomatic research. J Psychosom Res. 1993 Jan;37(1):19-32. doi: 10.1016/0022-3999(93)90120-5.
PubMed 8421257Keshavarz B, Murovec B, Mohanathas N, Golding JF. The Visually Induced Motion Sickness Susceptibility Questionnaire (VIMSSQ): Estimating Individual Susceptibility to Motion Sickness-Like Symptoms When Using Visual Devices. Hum Factors. 2023 Feb;65(1):107-124. doi: 10.1177/00187208211008687. Epub 2021 Apr 19.
PubMed 33874752Ahmadpour N, Randall H, Choksi H, Gao A, Vaughan C, Poronnik P. Virtual Reality interventions for acute and chronic pain management. Int J Biochem Cell Biol. 2019 Sep;114:105568. doi: 10.1016/j.biocel.2019.105568. Epub 2019 Jul 12.
PubMed 31306747Browning MHEM, Shin S, Drong G, McAnirlin O, Gagnon RJ, Ranganathan S, Sindelar K, Hoptman D, Bratman GN, Yuan S, Prabhu VG, Heller W. Daily exposure to virtual nature reduces symptoms of anxiety in college students. Sci Rep. 2023 Jan 23;13(1):1239. doi: 10.1038/s41598-023-28070-9.
PubMed 36690698Kashif M, Ahmad A, Bandpei MAM, Farooq M, Iram H, E Fatima R. Systematic review of the application of virtual reality to improve balance, gait and motor function in patients with Parkinson's disease. Medicine (Baltimore). 2022 Aug 5;101(31):e29212. doi: 10.1097/MD.0000000000029212.
PubMed 35945738
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Virtual Reality (VR) and Progressive Muscle Relaxation (PMR) in Stress Management Among Physiotherapy Students
- ClinicalTrials.gov ID
- NCT06028360
- Acronym / sponsor ID
- SSAHS 2023/02
- Conditions
- Stress
- Keywords
- Psychological stress, progressive muscle relaxation (PMR)
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Shalamar Institute of Health SciencesUniversity, hospital or other
- Study start
- 1 Oct 2023 (estimated)
- Primary completion
- 10 Nov 2023 (estimated)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 8 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.
The objective of this clinical trial is to observe the effect of Virtual Reality (VR) and Progressive muscle relaxation (PMR) in stressed individuals.
Procedure:
Students will be invited verbally and procedure will be explained to them. 20 students will be recruited randomly into control and experimental group. Stress will be predicted using multiple questionnaires. Pss is given before and after the intervention. The students in control group will be given 10 mins session of PMR for 3 consecutive days and in intervention group will be given 10 mins session of PMR followed by 8 mins session of VR for 3 consecutive days in which specific landscapes i.e mountains, forests, nightskies and beaches.
Detailed description
Introduction:
As stress appears to be a natural human response to difficult situations prompting us to address challenges and threats in our lives, prolonged stress may cause the fight or flight response to over-ride body's normal physiology and produce multiple psychological and physiological symptoms resulting in various negative health conditions such as cardiovascular disorders, GIT disturbances, hypertension etc. Moreover, a global survey of adolescents in 72 countries found 66% of students reported feeling stressed about academics and 37% of students felt anxiety relating to schoolwork. Many stress reduction interventions such as Progressive Muscular Relaxation (PMR), mindfulness meditation, deep breathing exercises, and guided imagery have been shown to reduce stress levels among individuals and are being used as traditional relaxation interventions.
Progressive muscle relaxation (PMR) originally known as Jacobson Muscle Relaxation Technique, was developed by Edmund Jacobson in the 1934. It is an actively engaging technique guiding the patients to consciously contract muscles to create tension and release it progressively. This is repeated until patients acquire complete relaxation. Many studies on PMR have proven it to be beneficial in decreasing stress and anxiety levels in many adults as well as children worldwide.
With emerging technology, innovative ideas, such as the use of VR (Virtual Reality) for stress management, have also been considered and studied. According to Cruz-Neira (1993), Virtual reality refers to immersive, interactive, multisensory, viewer-centered, 3D computer generated environments and the combination of technologies required building environments. In the healthcare sector, VR has been proved beneficial for balance and cognition training in cerebral palsy and stroke, and also has been observed to mitigate acute and chronic pain. It can provide rehabilitation, motivation and entertainment all at once. Further studies on its immersive effect suggest it to be helpful in stress management. Natural environments (forests, beaches, mountains etc ) viewed through VR, have shown to help individuals reduce their stress levels, anxiety disorders, and phobias. However, there is little research on individual preferences of different VR landscapes.
In Asia, research relevant to VR has been shown to have a positive effect on stress management in individuals with high stress and mood disorders. Effect of forest and water landscapes on stress management has also been discussed earlier. However, area for more research still remains.
In Pakistan, multiple researches have been conducted on the use of VR in health care and as a rehabilitative intervention for diseases such as stroke, parkinsons, cerebral palsy and amblyopia, but very limited evidence is available on the effect of VR on stress management. No such research has been conducted in this region or in our institution prior to our study.
A study conducted in India showed that the PSS score decreased from mean 22.2 to 16.5 while another study conducted in India indicated that PMR and talk therapy in college students, reduced percieved stress from PSS score of 32.30 to 23.03.
The purpose of our research is to investigate the effect of VR in stress management, the individual preferences of landscapes and its comparison with traditional relaxation technique such as Progressive Muscle Relaxation (PMR). This will help health-care workers improve stress management in a technology driven community.
Statistical analysis:
data will be entered and analyzed using SPSS 25. Numerical data like age, PSS score will be presented in the form of mean ± S.D whereas qualitative data like gender, Pre/Post intervention stress etc. will be presented in the form of Frequency (Percentage). After fulfilling parametric assumptions, Repeated measure ANOVA will be applied.
Potential benefits:
- The subjects receiving the interventions will experience reduced stress and anxiety.
- The subjects will be introduced to an innovative and immersive technology i.e., VR.
- A step will be taken forward towards the use of technology in stress management, along with a traditional relaxation technique such as Progressive muscle relaxation (PMR).
- The use of VR for stress management is cost effective and time saving.
Potential risks:
- Motion Sickness It will be tried to minimize by excluding the susceptible subjects, using Visually Induced Motion Sickness Susceptibility Questionnaire (VIMSSQ). Also subjects with any psychological or in-corrected eye sight will not be included in the study. In case the above mentioned risk develops during the intervention, the subject will be given rest.
- Increased Drop Out Rate If the required sample size is not met due to high drop out rate, new participants will be recruited and the procedure will be repeated until required amount of data is available.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- A Randomized Control Trial with a Control and an Experimental group that will be given intervention 3 consecutive days.
| Arm | Type | Receives |
|---|---|---|
| Progressive Muscle Relaxation | Active comparator | Other: Progressive Muscle RelaxationProgressive muscle relaxation will be applied for 15-20 minutes for 3 consecutive days for 1 week. |
| Virtual Reality | Experimental | Other: Progressive Muscle Relaxation, Device: Virtual Reality TherapyVirtual reality session will be given for 8 mins for 3 consecutive days for 1 week. |
Who may qualify
- Ages
- 18 to 24 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Students of either sex, aged between 18-24 years
- Students with Stress (through perceived stress scale PSS, any individual with a score above 14)
Key exclusion criteria (3 listed)
- Students more susceptible to motion sickness (Through VIMSSQ),
- Students with in-corrected eye-sight,
- Students with phobias relevant to landscapes/views of mountains, forests, beaches and night-skies.
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 |
|---|---|---|
| Progressive Muscle RelaxationAlso: PMRIntervention will be applied for 15-20 minutes 3 consecutive days a week for 1 week | Other | Progressive Muscle Relaxation, Virtual Reality |
| Virtual Reality TherapyAlso: VR TherapyTherapy through VR will be given for 8 minutes 3 times a week on consecutively for 1 week | Device | Virtual Reality |
Primary outcome
Stress Reduction
Time frame: the outcome will be determine at the base line of the treatment and at the 3rd day after initiation oftreatment
Reduction in Perceived Stress scale(PSS) from the previous reading will be considered as stress reduction. information will be collected before and after the treatment on each day. The scoring of Perceived Stress scale(PSS) ranges between 0-40, where 0-13 means low stress, 14-26 means moderate stress and 27-40 would be considered as high perceived stress
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2023.
- Background: PubMed 31455015Gao T, Zhang T, Zhu L, Gao Y, Qiu L. Exploring Psychophysiological Restoration and Individual Preference in the Different Environments Based on Virtual Reality. Int J Environ Res Public Health. 2019 Aug 26;16(17):3102. doi: 10.3390/ijerph16173102.
- Background: PubMed 31491931Wang X, Shi Y, Zhang B, Chiang Y. The Influence of Forest Resting Environments on Stress Using Virtual Reality. Int J Environ Res Public Health. 2019 Sep 5;16(18):3263. doi: 10.3390/ijerph16183263.
- Background: PubMed 31738679Allison S, Irwin Hamilton K, Yuan Y, Wallis Hague G. Assessment of Progressive Muscle Relaxation (PMR) as a Stress-Reducing Technique for First-Year Veterinary Students. J Vet Med Educ. 2020 Dec;47(6):737-744. doi: 10.3138/jvme.2018-0013. Epub 2019 Nov 15.
- Background: PubMed 34394986Ruotolo I, Berardi A, Sellitto G, Panuccio F, Polimeni A, Valente D, Galeoto G. Criterion Validity and Reliability of SF-12 Health Survey Version 2 (SF-12v2) in a Student Population during COVID-19 Pandemic: A Cross-Sectional Study. Depress Res Treat. 2021 Aug 4;2021:6624378. doi: 10.1155/2021/6624378. eCollection 2021.
- Background: PubMed 8421257Levenstein S, Prantera C, Varvo V, Scribano ML, Berto E, Luzi C, Andreoli A. Development of the Perceived Stress Questionnaire: a new tool for psychosomatic research. J Psychosom Res. 1993 Jan;37(1):19-32. doi: 10.1016/0022-3999(93)90120-5.
- Background: PubMed 33874752Keshavarz B, Murovec B, Mohanathas N, Golding JF. The Visually Induced Motion Sickness Susceptibility Questionnaire (VIMSSQ): Estimating Individual Susceptibility to Motion Sickness-Like Symptoms When Using Visual Devices. Hum Factors. 2023 Feb;65(1):107-124. doi: 10.1177/00187208211008687. Epub 2021 Apr 19.
- Background: PubMed 31306747Ahmadpour N, Randall H, Choksi H, Gao A, Vaughan C, Poronnik P. Virtual Reality interventions for acute and chronic pain management. Int J Biochem Cell Biol. 2019 Sep;114:105568. doi: 10.1016/j.biocel.2019.105568. Epub 2019 Jul 12.
- Background: PubMed 36690698Browning MHEM, Shin S, Drong G, McAnirlin O, Gagnon RJ, Ranganathan S, Sindelar K, Hoptman D, Bratman GN, Yuan S, Prabhu VG, Heller W. Daily exposure to virtual nature reduces symptoms of anxiety in college students. Sci Rep. 2023 Jan 23;13(1):1239. doi: 10.1038/s41598-023-28070-9.
- Background: PubMed 35945738Kashif M, Ahmad A, Bandpei MAM, Farooq M, Iram H, E Fatima R. Systematic review of the application of virtual reality to improve balance, gait and motor function in patients with Parkinson's disease. Medicine (Baltimore). 2022 Aug 5;101(31):e29212. doi: 10.1097/MD.0000000000029212.
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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.
Reema Khanam, DPT principal investigator
Shalamar Medical and Dental College
Laiba Khan, DPT principal investigator
Shalamar Medical and Dental College
Maha Sohail, DPT principal investigator
Shalamar Medical and Dental College
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Progressive Muscle Relaxation and Virtual Reality Therapy in people with Stress, run by Shalamar Institute of Health Sciences 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 2 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 28 Sep 2023. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Masooma Gull, M.S. (+92-42-111-205-205 ext. 528, masooma.gull@sihs.org.pk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Stress Reduction (time frame: the outcome will be determine at the base line of the treatment and at the 3rd day after initiation oftreatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06028360, which also lists 9 linked publications.
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 28 Sep 2023.