Implications of Stress Management Program

NCT04978974 | Completed DMC

• 1 other identifier: UOG/ASRB/Psych/3/18631/011
• Study Type: interventional
• Target: 110
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Chronic Conditions, Multiple

Keywords

Diabetes; Hypertension; Chronic Condition; Stress Management Program; Perceived Stress; Coping Strategies

Outcome Measures

Primary Outcomes (3)

• 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)

• 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)

• 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 Outcomes (1)

• Effects of stress management program as assessed using Baseline

  base line were used in 5th (two weeks and 3 days) and 10th session (one month and one week from first assessment)

Study Arms (1)

Patients with type 2 Diabetes mellitus and Hypertension

EXPERIMENTAL

patients with type 2 diabetes mellitus and hypertension were selected by using purposive sampling technique to apply stress management program

Behavioral: Stress Management Program

Interventions

Stress Management Program BEHAVIORAL

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

Patients with type 2 Diabetes mellitus and Hypertension

Eligibility Criteria

• Age: 31 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Gujrat: lead

Study Sites (1)

Jhelum Poly Clinic

Jhelum, Punjab Province, Pakistan

Location

Related 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.

  PMID: 31923232 BACKGROUND

MeSH Terms

Conditions

Multiple Chronic Conditions; Diabetes Mellitus; Hypertension; Chronic Disease

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Mphil Scholar, Priniciple Investigator, Psychologist, Department of Psychology, University of Gujrat

Model Details: The patients with chronic conditions which included type 2 diabetes and hypertension were selected through purposive sampling technique

Study Record Dates

• First Submitted: June 27, 2021
• First Posted: July 27, 2021
• Study Start: May 3, 2019
• Primary Completion: January 3, 2020
• Study Completion: December 29, 2020
• Last Updated: July 27, 2021

Record last verified: 2021-07

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)