Postpartum DisorderNCT06460649
Combined Effects Of Progressive Relaxation Techniques Along With Benson Relaxation Techniques
A study testing Progressive relaxation techniques and Benson relaxation techniques in people with Postpartum Disorder, run by Riphah International University at 1 site in Pakistan.
Trial summary
The postpartum (or postnatal) period begins after childbirth and is typically considered to last for six weeks. Stress is considered a response to any stressor within external or internal milieu, to stay in an adaptive mode using functional or dysfunctional coping skills. Read more about this study
- Who is it for?
- Ages 20 to 40 years, women only
- Conditions the study is for
- Postpartum Disorder
- What is being tested?
- Progressive relaxation techniques and Benson relaxation techniques
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- 1 sitePakistan
- Study dates
- 10 Dec 2023to 10 Jul 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 20 to 40 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- • Parity of women must not more than 3 times
- Start from 2nd week of postpartum female
- Women with aged group of 20- 40 were included in study.(24)
- Women who had Vaginal or c section delivery were included in study.
- Women with no postnatal complications were included in study
Who cannot join
- • Women with Diabetes Militias were excluded
- Women with Breast cancer were excluded
- Ovarian cancer were excluded
- Patient with dementia, delusional disorder were excluded
- Women who use Alcohol or substance abuse were excluded
- Women who had a history of psychiatric disorders were excluded
- Severed obesity ( BMI more than 40)
Trial locations and contacts
1 site in 1 country.
Pakistan1 site, 1 recruiting
- Recruiting
Jinnah Hospital Lahore
Lahore, Punjab Province, 54000
Sabiha Arshad, M.phill, 03248495979, s.arshad@riphah.edu.pk
Sadaf Arif, Dpt
About this study
Official title: Combined Effects Of Progressive Relaxation Techniques Along With Benson Relaxation Techniques on Stress Fatigue and Quality of Life on Postpartum Females
The postpartum (or postnatal) period begins after childbirth and is typically considered to last for six weeks. Stress is considered a response to any stressor within external or internal milieu, to stay in an adaptive mode using functional or dysfunctional coping skills. It initiates an alterable mode that ultimately becomes a prolonged adaptive struggle The study will be a randomized controlled trial and will be conducted in Jinnah hospital, Lahore. This study will be completed in a time duration of 8 months after the approval of synopsis. Nonprobability convenience sampling technique will be used, and participants will be recruited in study after randomization. The subjects will be divided into two groups and group A will receive progressive relaxation technique along with Benson relaxing technique. and group B will receive progressive relaxation technique and deep breathing exercises will be used as a baseline treatment. The tools that will be used for pre and post treatment assessment are Postpartum fatigue scale (PFS), Perceived Stress Scale (PSS_10), WHOQOL-BREF Scale. The data will be assessed after 12 weeks. After data collection data will be analyzed by using SPSS version 25.
Read the detailed description
The postpartum (or postnatal) period begins after childbirth and is typically considered to last for six weeks. Postpartum period can be a challenging time for many women, as they often experience increased stress levels, fatigue, and a change in their overall quality of life. Stress is considered a response to any stressor within external or internal milieu, to stay in an adaptive mode using functional or dysfunctional coping skills. It initiates an alterable mode that ultimately becomes a prolonged adaptive struggle when an individual cannot find the right coping skills, which may then become a long term dysfunctional state, hence a chronic psychiatric condition.
The study will be a randomized controlled trial and will be conducted in Jinnah hospital, Lahore. This study will be completed in time duration of 5_6 months after the approval of synopsis. Non probability convenience sampling technique will be used and participants will be recruited in study after randomization. The subjects will be divided into two groups and the group A will receive progressive relaxation technique along with Benson relaxing technique. and group B will receive progressive relaxation technique and deep breathing exercises will be used as a baseline treatment. The tools that will be used for pre and post treatment assessment are Postpartum fatigue scale(PFS), Perceived Stress Scale (PSS_10), WHOQOL-BREF Scale. The data will be assessed after 5 days 45min per treatment session. After data collection data will be analyzed by using SPSS version 25.
Key words: Fatigue, progressive Relaxation technique, Postpartum period, Postpartum women, Quality of life, Stress
- Conditions
- Postpartum Disorder
- Being tested
- Progressive relaxation techniques, Benson relaxation techniques
- Keywords
- Fatigue, Postpartum relaxation techniques, Postpartum period, Postpartum women, Quality of life, Stress
- Medical subject headings
- Puerperal Disorders, Fatigue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Progressive relaxation techniquesOther
Participants received Progressive muscle relaxation along with Benson relaxing 3 times a week for 12 weeks. 36 sessions overall
Benson relaxation techniquesOther
Participants received Benson relaxation techniques 3 times a week for 12 weeks. 36 sessions overall.
| Study group | Role | What they receive |
|---|---|---|
| Progressive relaxation techniques+Benson relaxation techniques | Experimental | Participants in group A will receive progressive relaxation techniques along benson relaxation sessions will be conducted 3 times a week for 12 weeks . Total number of sessions will be 3 Receives: Other: Progressive relaxation techniques; Other: Benson relaxation techniques |
| Progressive relaxation techniques | Active comparator | Participants in group B will receive progressive relaxation techniques only. Sessions will be conducted 3 times a week for 12 weeks.36 sessions over all Receives: Other: Progressive relaxation techniques |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postpartum fatigue scale
Postpartum fatigue scale four-point scale to respond to the PFS questionnaire, which included-physical stress, mental stress, sleep deprivation, exploratory factor analysis, it was determined that PAFS consisted of 13 items, 6 items in the "Physical Fatigue" subdimension, 4 items in the "Emotional" subdimension, and 3 items in the "Cognitive" subdimension. The three-factor scale structure supported confirmatory factor analysis. On the total scale, Cronbach's α was found to be 0.91.(24)
Measured: 12 weeks
Perceived stress scale
The Perceived Stress Scale (PSS) is a classic stress assessment instrument. The tool, while originally developed in 1983,. The questions in this scale ask about your feelings and thoughts during the last month.. The best approach is to answer fairly quickly. That is, don't try to count up the number of times you felt a particular way; rather indicate the alternative that seems like a reasonable estimate Figuring Your PSS Score You can determine your PSS score by following these directions: • First, reverse your scores for questions 4, 5, 7, and 8.
On these 4 questions, change the scores like this: 0 = 4, 1 = 3, 2 = 2, 3 = 1, 4 = 0.
Measured: 12 weeks
WHOQOL-BREF Scale
The World Health Organization Quality of Life Brief Version (WHOQOL-BREF) is an abbreviated, 26-item version of the 100-item WHOQOL-100 quality of life measure. The
The WHOQOL-BREF is a 26-item instrument consisting of four domains: physical health (7 items), psychological health (6 items), social relationships (3 items), and environmental health (8 items);. Each individual item of the WHOQOL-BREF is scored from 1 to 5 on a response scale, which is stipulated as a five-point ordinal scale. The scores are then transformed linearly to a 0-100-scale . The physical health domain includes items on mobility, daily activities, functional capacity, energy, pain, and sleep. the 8-item the reliability of the WHOQOL-5 was below the acceptable threshold (PSI = 0.66). Reliability of the EUROHIS-QOL-8 was satisfactory (PSI = 0.79)(24)
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jun 2024
- Study start10 Dec 2023
- Primary completion30 Jun 2024 (estimated)
- Study completion10 Jul 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postpartum DisorderStudies of the same condition, open and under way.
- More trials run by Riphah International UniversityThe 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
- 54 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sabiha Arshad, M.phill, Principal investigator, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06460649
- Sponsor's protocol ID
- REC/RCR&AHS/23/0586
- Status last verified
- Jun 2024
- First submitted
- 11 Jun 2024
- Last updated
- 14 Jun 2024
- Results posted
- 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 14 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Combined Effects Of Progressive Relaxation Techniques Along With Benson Relaxation Techniques on Stress Fatigue and Quality of Life on Postpartum Females
- ClinicalTrials.gov ID
- NCT06460649
- Acronym / sponsor ID
- REC/RCR&AHS/23/0586
- Conditions
- Postpartum Disorder
- Keywords
- Fatigue, Postpartum relaxation techniques, Postpartum period, Postpartum women, Quality of life, Stress
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 54 participants (estimated)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 10 Dec 2023 (actual)
- Primary completion
- 30 Jun 2024 (estimated)
- Study completion
- 10 Jul 2024 (estimated)
- First posted
- 14 Jun 2024 (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 postpartum (or postnatal) period begins after childbirth and is typically considered to last for six weeks. Stress is considered a response to any stressor within external or internal milieu, to stay in an adaptive mode using functional or dysfunctional coping skills. It initiates an alterable mode that ultimately becomes a prolonged adaptive struggle The study will be a randomized controlled trial and will be conducted in Jinnah hospital, Lahore. This study will be completed in a time duration of 8 months after the approval of synopsis. Nonprobability convenience sampling technique will be used, and participants will be recruited in study after randomization. The subjects will be divided into two groups and group A will receive progressive relaxation technique along with Benson relaxing technique. and group B will receive progressive relaxation technique and deep breathing exercises will be used as a baseline treatment. The tools that will be used for pre and post treatment assessment are Postpartum fatigue scale (PFS), Perceived Stress Scale (PSS_10), WHOQOL-BREF Scale. The data will be assessed after 12 weeks. After data collection data will be analyzed by using SPSS version 25.
Detailed description
The postpartum (or postnatal) period begins after childbirth and is typically considered to last for six weeks. Postpartum period can be a challenging time for many women, as they often experience increased stress levels, fatigue, and a change in their overall quality of life. Stress is considered a response to any stressor within external or internal milieu, to stay in an adaptive mode using functional or dysfunctional coping skills. It initiates an alterable mode that ultimately becomes a prolonged adaptive struggle when an individual cannot find the right coping skills, which may then become a long term dysfunctional state, hence a chronic psychiatric condition.
The study will be a randomized controlled trial and will be conducted in Jinnah hospital, Lahore. This study will be completed in time duration of 5_6 months after the approval of synopsis. Non probability convenience sampling technique will be used and participants will be recruited in study after randomization. The subjects will be divided into two groups and the group A will receive progressive relaxation technique along with Benson relaxing technique. and group B will receive progressive relaxation technique and deep breathing exercises will be used as a baseline treatment. The tools that will be used for pre and post treatment assessment are Postpartum fatigue scale(PFS), Perceived Stress Scale (PSS_10), WHOQOL-BREF Scale. The data will be assessed after 5 days 45min per treatment session. After data collection data will be analyzed by using SPSS version 25.
Key words: Fatigue, progressive Relaxation technique, Postpartum period, Postpartum women, Quality of life, Stress
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Progressive relaxation techniques+Benson relaxation techniques | Experimental | Other: Progressive relaxation techniques, Other: Benson relaxation techniquesParticipants in group A will receive progressive relaxation techniques along benson relaxation sessions will be conducted 3 times a week for 12 weeks . Total number of sessions will be 3 |
| Progressive relaxation techniques | Active comparator | Other: Progressive relaxation techniquesParticipants in group B will receive progressive relaxation techniques only. Sessions will be conducted 3 times a week for 12 weeks.36 sessions over all |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- • Parity of women must not more than 3 times
Key exclusion criteria (7 listed)
- • Women with Diabetes Militias were excluded
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 relaxation techniquesParticipants received Progressive muscle relaxation along with Benson relaxing 3 times a week for 12 weeks. 36 sessions overall | Other | Progressive relaxation techniques, Progressive relaxation techniques+Benson relaxation techniques |
| Benson relaxation techniquesParticipants received Benson relaxation techniques 3 times a week for 12 weeks. 36 sessions overall. | Other | Progressive relaxation techniques+Benson relaxation techniques |
Primary outcome
Postpartum fatigue scale
Time frame: 12 weeks
Postpartum fatigue scale four-point scale to respond to the PFS questionnaire, which included-physical stress, mental stress, sleep deprivation, exploratory factor analysis, it was determined that PAFS consisted of 13 items, 6 items in the "Physical Fatigue" subdimension, 4 items in the "Emotional" subdimension, and 3 items in the "Cognitive" subdimension. The three-factor scale structure supported confirmatory factor analysis. On the total scale, Cronbach's α was found to be 0.91.(24)
Perceived stress scale
Time frame: 12 weeks
The Perceived Stress Scale (PSS) is a classic stress assessment instrument. The tool, while originally developed in 1983,. The questions in this scale ask about your feelings and thoughts during the last month.. The best approach is to answer fairly quickly. That is, don't try to count up the number of times you felt a particular way; rather indicate the alternative that seems like a reasonable estimate Figuring Your PSS Score You can determine your PSS score by following these directions: • First, reverse your scores for questions 4, 5, 7, and 8. On these 4 questions, change the scores like this: 0 = 4, 1 = 3, 2 = 2, 3 = 1, 4 = 0.
WHOQOL-BREF Scale
Time frame: 12 weeks
The World Health Organization Quality of Life Brief Version (WHOQOL-BREF) is an abbreviated, 26-item version of the 100-item WHOQOL-100 quality of life measure. The The WHOQOL-BREF is a 26-item instrument consisting of four domains: physical health (7 items), psychological health (6 items), social relationships (3 items), and environmental health (8 items);. Each individual item of the WHOQOL-BREF is scored from 1 to 5 on a response scale, which is stipulated as a five-point ordinal scale. The scores are then transformed linearly to a 0-100-scale . The physical health domain includes items on mobility, daily activities, functional capacity, energy, pain, and sleep. the 8-item the reliability of the WHOQOL-5 was below the acceptable threshold (PSI = 0.66). Reliability of the EUROHIS-QOL-8 was satisfactory (PSI = 0.79)(24)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jun 2024.
- 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.
Sabiha Arshad, M.phill principal investigator
Riphah International University
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 relaxation techniques and Benson relaxation techniques in people with Postpartum Disorder, run by Riphah International University 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 7 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 14 Jun 2024. 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 Iqbal Tariq, PhD (03458236752, iqbal.tariq@riphah.edu.pk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postpartum fatigue scale (time frame: 12 weeks). The study lists 3 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 14 Jun 2024.