- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06460649
Combined Effects Of Progressive Relaxation Techniques Along With Benson Relaxation Techniques
Combined Effects Of Progressive Relaxation Techniques Along With Benson Relaxation Techniques on Stress Fatigue and Quality of Life on Postpartum Females
Study Overview
Status
Conditions
Intervention / Treatment
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
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Iqbal Tariq, PhD
- Phone Number: 03458236752
- Email: iqbal.tariq@riphah.edu.pk
Study Locations
-
-
Punjab
-
Lahore, Punjab, Pakistan, 54000
- Recruiting
- Jinnah Hospital Lahore
-
Contact:
- Sabiha Arshad, M.Phill
- Phone Number: 03248495979
- Email: s.arshad@riphah.edu.pk
-
Sub-Investigator:
- Sadaf Arif, Dpt
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
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
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
Sponsor
Investigators
- Principal Investigator: Sabiha Arshad, M.Phill, Riphah International University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- REC/RCR&AHS/23/0586
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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.
Clinical Trials on Postpartum Disorder
-
Women's College HospitalCanadian Institutes of Health Research (CIHR); Michael Garron HospitalCompletedPostpartum Depression | Postpartum Anxiety | Postpartum Blues | Postpartum Mood DisorderCanada
-
University of British ColumbiaCanadian Institutes of Health Research (CIHR); Women's Health Research Institute...CompletedPostpartum Depression | Perinatal Disorder | Postpartum Disorder | Perinatal Depression | Postpartum Anxiety | Postnatal DepressionCanada
-
Hacettepe UniversityCompletedQuality of Life | Postpartum Depression | Nursing Caries | Nurse's Role | Postpartum Disorder | Postpartum AnxietyTurkey
-
Jordan University of Science and TechnologyActive, not recruitingPostpartum Depression | Postpartum Depression (PPD)Jordan
-
Marinus PharmaceuticalsCompletedBehavioral Symptoms | Depressive Disorder | Depression | Mood Disorders | Pregnancy Complications | Depression, Postpartum | Mental Disorder | Postpartum Disorder | PPD | Postpartum BluesUnited States
-
Universidad del DesarrolloUniversity of BarcelonaNot yet recruitingPostpartum Anxiety | Postpartum Depression (PPD)
-
McMaster UniversityActive, not recruitingPostpartum Anxiety | Postpartum Depression (PPD)Canada
-
Johns Hopkins UniversityUniversity of VirginiaCompletedPostpartum Depression | Bipolar Disorder | Major Depressive Disorder | Postpartum PsychosisUnited States
-
Marta MarciniakUniversity of ZurichRecruitingStress | Postpartum Anxiety | Postpartum Depressive DisorderSwitzerland
-
Universidad Complutense de MadridUniversidad Pontificia de SalamancaRecruitingPostpartum Depression | Postpartum DisorderSpain
Clinical Trials on Progressive relaxation techniques
-
Ataturk UniversityCompletedStress | Anxiety | Nursing Students | Relaxation ProgramTurkey
-
Johns Hopkins UniversityRecruitingAnxiety | Sleep Disturbance | Depressive Symptoms | Pruritus | Burn | Virtual Reality | Progressive Muscle Relaxation | Burn Injury | Fatigue Symptom | Chronic Pain Following Thermal Burn Injury | Non-Pharmacological InterventionsUnited States
-
Ondokuz Mayıs UniversityThe Scientific and Technological Research Council of TurkeyCompletedDepression | Stress, Psychological | Anxiety | Mental Health | Adaptation, Psychological | Psychophysiologic Disorders | Students, Nursing | Relaxation Therapy | Progressive Muscle Relaxation Exercise | Progressive Relaxation ExerciseTurkey (Türkiye)
-
Riphah International UniversityCompletedPost-Hysterectomy Vaginal Vault ProlapsePakistan
-
Gazi UniversityCompletedProgressive Muscle Relaxation ExerciseTurkey
-
Palo Alto Veterans Institute for ResearchVA Palo Alto Health Care System; Brain & Behavior Research FoundationCompletedAnxiety DisordersUnited States
-
Istanbul University - CerrahpasaRecruitingPre-Eclampsia | Maternal Health | Virtual Reality | Relaxation | Fetal MonitoringTurkey (Türkiye)
-
University of Health Sciences LahoreActive, not recruitingPremenstrual Syndrome-PMSPakistan
-
Dow University of Health SciencesRecruitingLow Back Pain | Chronic Low-back Pain | Low Back Pain, Mechanical | Mechanical Low Back Pain | Pain, Chronic | Pain, Back | Lower Back Pain Chronic | CLBP - Chronic Low Back PainPakistan
-
Bitlis Eren UniversityCompletedPain, Postoperative | Muscle Relaxation | Breathing, Mouth | KinesiophobiaTurkey (Türkiye)