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Implications of Stress Management Program

Primary Purpose

Chronic Conditions, Multiple

Status
Completed
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
Stress Management Program
Sponsored by
University of Gujrat
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Conditions, Multiple focused on measuring Diabetes, Hypertension, Chronic Condition, Stress Management Program, Perceived Stress, Coping Strategies

Eligibility Criteria

31 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Jhelum Poly Clinic

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Patients with type 2 Diabetes mellitus and Hypertension

Arm Description

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

Outcomes

Primary Outcome Measures

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
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
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

Secondary Outcome Measures

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).

Full Information

First Posted
June 27, 2021
Last Updated
July 24, 2021
Sponsor
University of Gujrat
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1. Study Identification

Unique Protocol Identification Number
NCT04978974
Brief Title
Implications of Stress Management Program
Official Title
Stress, Coping Strategies and Quality of Life Among Patients With Chronic Conditions: Implications of Stress Management Program
Study Type
Interventional

2. Study Status

Record Verification Date
July 2021
Overall Recruitment Status
Completed
Study Start Date
May 3, 2019 (Actual)
Primary Completion Date
January 3, 2020 (Actual)
Study Completion Date
December 29, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Gujrat

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Conditions, Multiple
Keywords
Diabetes, Hypertension, Chronic Condition, Stress Management Program, Perceived Stress, Coping Strategies

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
The patients with chronic conditions which included type 2 diabetes and hypertension were selected through purposive sampling technique
Masking
None (Open Label)
Allocation
N/A
Enrollment
110 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Patients with type 2 Diabetes mellitus and Hypertension
Arm Type
Experimental
Arm Description
patients with type 2 diabetes mellitus and hypertension were selected by using purposive sampling technique to apply stress management program
Intervention Type
Behavioral
Intervention Name(s)
Stress Management Program
Intervention Description
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 Outcome Measure Information:
Title
Effects of stress management program as assessed using Perceived Stress Scale
Description
Consisted of 10 items, Scoring: 0 to 1, The Higher score shows more stress
Time Frame
10th session (one month and one week from first assessment)
Title
Effects of stress management program as assessed using Health-Related Quality of Life
Description
Consisted of 26 items, Scoring: 1 to 5, The higher score shows better HRQOL
Time Frame
10th session (one month and one week from first assessment)
Title
Effects of stress management program as assessed using Coping Strategies Questionnaire
Description
Consisted of 62 items, Scoring: 1 to 5, The higher score shows high use of coping strategies
Time Frame
10th session (one month and one week from first assessment)
Secondary Outcome Measure Information:
Title
Effects of stress management program as assessed using Baseline
Description
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).
Time Frame
base line were used in 5th (two weeks and 3 days) and 10th session (one month and one week from first assessment)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
31 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Jhelum Poly Clinic
City
Jhelum
State/Province
Punjab
Country
Pakistan

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
Due to data confidentiality from the participants, there is no plan of IPD available
Citations:
PubMed Identifier
31923232
Citation
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.
Results Reference
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Implications of Stress Management Program

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