Combined Effects Of Progressive Relaxation Techniques Along With Benson Relaxation Techniques

June 11, 2024 updated by: Riphah International University

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.

Study Overview

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 Type

Interventional

Enrollment (Estimated)

54

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

    • Punjab
      • Lahore, Punjab, Pakistan, 54000
        • Recruiting
        • Jinnah Hospital Lahore
        • Contact:
        • Sub-Investigator:
          • Sadaf Arif, Dpt

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

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:

  • • 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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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
Participants received Progressive muscle relaxation along with Benson relaxing 3 times a week for 12 weeks. 36 sessions overall
Participants received Benson relaxation techniques 3 times a week for 12 weeks. 36 sessions overall.
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
Participants received Progressive muscle relaxation along with Benson relaxing 3 times a week for 12 weeks. 36 sessions overall

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
12 weeks
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.

12 weeks
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)

12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Sabiha Arshad, M.Phill, Riphah International University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 10, 2023

Primary Completion (Estimated)

June 30, 2024

Study Completion (Estimated)

July 10, 2024

Study Registration Dates

First Submitted

June 11, 2024

First Submitted That Met QC Criteria

June 11, 2024

First Posted (Actual)

June 14, 2024

Study Record Updates

Last Update Posted (Actual)

June 14, 2024

Last Update Submitted That Met QC Criteria

June 11, 2024

Last Verified

June 1, 2024

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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