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NCT Number: NCT04978974

Implications of Stress Management Program

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.

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Key information

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Primary outcomes

  1. Effects of stress management program as assessed using Perceived Stress Scale

    Time frame: 10th session (one month and one week from first assessment)

    Consisted of 10 items, Scoring: 0 to 1, The Higher score shows more stress

  2. Effects of stress management program as assessed using Health-Related Quality of Life

    Time frame: 10th session (one month and one week from first assessment)

    Consisted of 26 items, Scoring: 1 to 5, The higher score shows better HRQOL

  3. Effects of stress management program as assessed using Coping Strategies Questionnaire

    Time frame: 10th session (one month and one week from first assessment)

    Consisted of 62 items, Scoring: 1 to 5, The higher score shows high use of coping strategies

Secondary outcomes

  1. Effects of stress management program as assessed using Baseline

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

    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).

Sponsors and collaborators

Lead sponsor

University of Gujrat

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Jul 27, 2021
Registry last updated
Jul 27, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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