Implications of Stress Management Program

Chronic Conditions, Multiple Clinical Trial

Official title:

Stress, Coping Strategies and Quality of Life Among Patients With Chronic Conditions: Implications of Stress Management Program

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04978974
• Other study ID #: UOG/ASRB/Psych/3/18631/011
• Status: Completed
• Phase: N/A
• Start date: May 3, 2019
• Est. completion date: December 29, 2020

Study information

• Verified date: July 2021
• Source: University of Gujrat
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Previous studies indicated that patients with diabetes mellitus and hypertension had higher level of perceived stress, used maladaptive coping strategies and poor health-related quality of life. Therefore, stress management program was applied to reduce their perceived stress, improve their coping strategies, improve their health-related quality of life and psychological health of the patients with type 2 diabetes mellitus and hypertension in current study. The main objectives of the current study were to observe the effects of stress management program on perceived stress, coping strategies and health-related quality of life using pre-experimental research design. Patients with diabetes mellitus type 2 and hypertension were selected through purposive sampling technique to apply the eclectic approach of the stress management program. Total 110 patients with type 2 diabetes and hypertension completed the program from 114 patients who gave inform consent for participation in the first session. Perceived stress scale, WHOQOL and Coping strategies questionnaire were administered at the pre and post-levels of the program. Further, base line of targeted domains variables was also filled from the participants at pre, mid and post-levels to access the efficacy of the program which was formulated according to previous research data by the researcher. The stress Management program consisted of 10 session which were delivered to eight groups (diabetic and Hypertensive) in five weeks. Each session had the duration 90 minutes and two sessions were conducted in one week.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 110
• Est. completion date: December 29, 2020
• Est. primary completion date: January 3, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 31 Years to 60 Years

Eligibility

Inclusion Criteria:

• patients with type II diabetes or hypertension with at least three months duration of illness
• had not attended any psychological intervention or stress management program earlier

Exclusion Criteria:

• Patients who had any other physical/ mental illnesses along with diabetes or hypertension
• Patients with type I diabetes
• Patients with gestational diabetes or hypertension
• Had diabetes or hypertensive condition from less than three month
• Had co morbidity of diabetes and hypertensive chronic conditions

Related Conditions & MeSH terms

• Chronic Conditions, Multiple
• Disease
• Multiple Chronic Conditions

Intervention

Behavioral:
• Stress Management Program
Stress management program includes different techniques such as relaxation technique, psycho-education, laughing, emotional freedom technique, referenting, cognitive restructuring, rational emotive imagery, time management, anger management, assertiveness and social support

Locations

Country	Name	City	State
Pakistan	Jhelum Poly Clinic	Jhelum	Punjab

Sponsors (1)

Lead Sponsor	Collaborator
University of Gujrat

Country where clinical trial is conducted

Pakistan, 

References & Publications (1)

Alshayban D, Joseph R. Health-related quality of life among patients with type 2 diabetes mellitus in Eastern Province, Saudi Arabia: A cross-sectional study. PLoS One. 2020 Jan 10;15(1):e0227573. doi: 10.1371/journal.pone.0227573. eCollection 2020. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Effects of stress management program as assessed using Perceived Stress Scale	Consisted of 10 items, Scoring: 0 to 1, The Higher score shows more stress	10th session (one month and one week from first assessment)
Primary	Effects of stress management program as assessed using Health-Related Quality of Life	Consisted of 26 items, Scoring: 1 to 5, The higher score shows better HRQOL	10th session (one month and one week from first assessment)
Primary	Effects of stress management program as assessed using Coping Strategies Questionnaire	Consisted of 62 items, Scoring: 1 to 5, The higher score shows high use of coping strategies	10th session (one month and one week from first assessment)
Secondary	Effects of stress management program as assessed using Baseline	20 targeted domains which included information about the illness, information about the causes of illness, information about the treatment of illness, efforts to control the level of illness, application of domestic tips, hopefulness, anxiety, negative thoughts, problems in daily activities, problems in social relationships, anger, appetite problems, sleep problems, concentration problems, body pain, fatigue, absent mind, unhealthy diet, loneliness and restlessness at pre, mid and post levels of stress management program. Rating scale ranges from 0-10 (0 shows there is absence of the target construct while 10 shows the high level of target construct).	base line were used in 5th (two weeks and 3 days) and 10th session (one month and one week from first assessment)