Combined Effects Of Progressive Relaxation Techniques Along With Benson Relaxation Techniques

NCT06460649 | Recruiting

• 1 other identifier: REC/RCR&AHS/23/0586
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Postpartum Disorder

Keywords

Fatigue; Postpartum relaxation techniques; Postpartum period; Postpartum women; Quality of life; Stress

Outcome Measures

Primary Outcomes (3)

• 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)

  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.

  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)

  12 weeks

Study Arms (2)

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

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

Other: Progressive relaxation techniques

Interventions

Progressive relaxation techniques OTHER

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

Progressive relaxation techniques; Progressive relaxation techniques+Benson relaxation techniques

Benson relaxation techniques OTHER

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

Progressive relaxation techniques+Benson relaxation techniques

Eligibility Criteria

• Age: 20 Years - 40 Years
• Gender Eligibility Details: Female (postpartum)
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Riphah International University: lead

Study Sites (1)

Jinnah Hospital Lahore

Lahore, Punjab Province, 54000, Pakistan

RECRUITING

MeSH Terms

Conditions

Puerperal Disorders; Fatigue

Condition Hierarchy (Ancestors)

Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Sabiha Arshad, M.phill

  Riphah International University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Iqbal Tariq, PhD

CONTACT

03458236752; iqbal.tariq@riphah.edu.pk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 11, 2024
• First Posted: June 14, 2024
• Study Start: December 10, 2023
• Primary Completion: June 30, 2024
• Study Completion: July 10, 2024
• Last Updated: June 14, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)