Effect of Serenity Therapy on Symptoms Distress, Coping Styles, and Emotional Regulation Among Geriatric Patients Undergoing Hemodialysis: a Randomized Controlled Trial

Not Applicable

Recruiting

• Conditions: Geriatric Patients
• Interventions: Behavioral: Sernity intervention

• Registration Number: NCT06255184
• Lead Sponsor: Alexandria University

Brief Summary

Our research aims to examine the effect of the serenity therapy on symptoms distress, coping styles, and emotional regulation among geriatric patients undergoing hemodialysis. This study highlights the following question: what is the effect of the serenity therapy on symptoms distress, coping styles, and emotional regulation among geriatric patients undergoing hemodialysis.

Detailed Description

In order to conduct this study, a randomized controlled trial research design was followed. The selected sitting for this study was the hemodialysis unit of the National Medical Institute at Damanhur city, El-Behaira Governorate, Egypt. Geriatric patients who were recruited for this study, meet the following inclusion criteria; being sixty years or more, scheduled for two or three weekly hemodialysis sessions for a minimum of three months, and having previously undergone hemodialysis for at least six months.

Study Timeline

• Study Start: 2024-01-01
• Status Verified: 2024-02
• Study First Submitted: 2024-02-04
• Study First Submitted QC: 2024-02-04
• Last Update Submitted: 2024-02-04
• Study First Posted: 2024-02-13
• Last Update Posted: 2024-02-13
• Primary Completion: 2024-04-01
• Study Completion: 2024-04-15

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

• Being sixty years or more
• Scheduled for two or three weekly hemodialysis sessions for a minimum of three months
• Having previously undergone hemodialysis for at least six months.

Exclusion Criteria

• having kidney transplant or peritoneal dialysis, hearing or vision disorders that could impede communication, previous participation in serenity therapy program, and getting psychiatric or psychosocial treatment

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Serenity GROUP	Sernity intervention	40 geriatric patients for the serenity group. They will receive the routine care in addition to the serenity therapy which included 8 sessions (1 introductory session, 4 face to face sessions at dialysis unit , and 3 mobile based sessions at home).

Primary Outcome Measures

Name	Time	Method
Hemodialysis Symptoms Distress-22 scale	3 months	The Hemodialysis Symptoms Distress scale-22 (HSD-22) is developed by Chen et al. (2021) to determine the symptom clusters that HD patients experience. It consists of 22 items that are classified into five subscales: sleep disturbance, musculoskeletal discomfort, cardiopulmonary distress, inadequate energy/vitality, and gastrointestinal distress.
Coping Orientation to Problems Experienced Inventory	3 months	A 28-item self-report inventory called the Brief COPE Scale was developed by Carver (1997) to assess the various coping mechanisms and responses that an individual may utilize during a stressful life situation including dangerous diseases.
The Emotion Regulation Questionnaire	3 months	It is a 10-item questionnaire used to assess participants' tendency to control their emotions using two subscales; cognitive reappraisal (6 items) and expressive suppression (4 items) (Gross\& John, 2003).

Trial Locations

Locations (2)

Hemodialysis unit of the National Medical Institute; 🇪🇬 Damanhur, El-Behaira Governorate, Egypt., Egypt

Faculty of Nursing, Alexandria university; 🇪🇬 Alexandria, Egypt