ClinicalTrials.gg
RecruitingNCT06460649Updated Jun 14, 2024

Combined Effects Of Progressive Relaxation Techniques Along With Benson Relaxation Techniques

An interventional study of Progressive relaxation techniques and Benson relaxation techniques in Postpartum Disorder, sponsored by Riphah International University. Recruiting at 1 site in Pakistan. Open to female participants aged 20 Years to 40 Years. Per ClinicalTrials.gov, last updated 2024-06-14.

Sponsored by Riphah International University · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Jun 2024, 2 years 4 months ago, but the record still lists the study as recruiting.
  • Registered 6 months after the study started (first participant enrolled Dec 2023, registered Jun 2024).
  • Started Dec 2023; still recruiting 2 years 11 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
54
Allocation
Randomized
Ages
20 Years to 40 Years
Sex
Female
01

Study 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. 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

02

Conditions studied

  • Postpartum Disorder

Keywords

  • Fatigue
  • Postpartum relaxation techniques
  • Postpartum period
  • Postpartum women
  • Quality of life
  • Stress
03

In context

Puerperal Disorders

40 studies on the registry are indexed under Puerperal Disorders; 10 are open to participants now.

This study's planned enrollment of 54 is below the median of 81 across 32 interventional studies indexed under Puerperal Disorders.

Browse Puerperal Disorders studies →

Lead sponsor

Riphah International University is the lead sponsor of 2,193 studies on the registry; 650 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years to 40 Years
Sexes eligible
Female
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

    • 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

Exclusion criteria

Exclusion Criteria:

    • 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 ( more than 40)
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

BMI (body mass index)

Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.

What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
54 participants (estimated)

Study arms

  • Experimental
    Progressive relaxation techniques+Benson relaxation techniques

    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

    Other: Progressive relaxation techniques · Other: Benson relaxation techniques

  • Active comparator
    Progressive relaxation techniques

    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

    Other: Progressive relaxation techniques

Interventions

  • OtherProgressive relaxation techniques

    Participants received Progressive muscle relaxation along with Benson relaxing 3 times a week for 12 weeks. 36 sessions overall

  • OtherBenson relaxation techniques

    Participants received Benson relaxation techniques 3 times a week for 12 weeks. 36 sessions overall.

06

What researchers measure

Primary outcomes

  1. 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)

    Time frame: 12 weeks

  2. 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.

    Time frame: 12 weeks

  3. 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)

    Time frame: 12 weeks

07

Study locations

1 of 1 sites recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 14, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06460649
Responsible party
Sponsor
First posted
Jun 14, 2024
Start date
Dec 10, 2023
Primary completion
Jun 30, 2024 (estimated)
Completion
Jul 10, 2024 (estimated)
Last update
Jun 14, 2024

Study contacts

Iqbal Tariq, PhD
Contact
iqbal.tariq@riphah.edu.pk
03458236752
Sabiha Arshad, M.phill
principal investigator · Riphah International University

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Interested in this study?

Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.

Contact study team

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion