Combined Effects Of Progressive Relaxation Techniques Along With Benson Relaxation Techniques

Postpartum Disorder Clinical Trial

Official title:

Combined Effects Of Progressive Relaxation Techniques Along With Benson Relaxation Techniques on Stress Fatigue and Quality of Life on Postpartum Females

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06460649
• Other study ID #: REC/RCR&AHS/23/0586
• Status: Recruiting
• Phase: N/A
• Start date: December 10, 2023
• Est. completion date: July 10, 2024

Study information

• Verified date: June 2024
• Source: Riphah International University
• Contact: Iqbal Tariq, PhD
• Phone: 03458236752
• Email: iqbal.tariq[@]riphah.edu.pk
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 54
• Est. completion date: July 10, 2024
• Est. primary completion date: June 30, 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 20 Years to 40 Years

Eligibility

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)

Related Conditions & MeSH terms

• Postpartum Disorder
• Puerperal Disorders

Intervention

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

Locations

Country	Name	City	State
Pakistan	Jinnah Hospital Lahore	Lahore	Punjab

Sponsors (1)

Lead Sponsor	Collaborator
Riphah International University

Country where clinical trial is conducted

Pakistan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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 a was found to be 0.91.(24)	12 weeks
Primary	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
Primary	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