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

February 4, 2024 updated by: Mahmoud Khedr, Alexandria University
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

80

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Alexandria, Egypt
        • Recruiting
        • Faculty of Nursing, Alexandria University
        • Contact:
    • El-Behaira Governorate, Egypt.
      • Damanhur, El-Behaira Governorate, Egypt., Egypt
        • Recruiting
        • Hemodialysis unit of the National Medical Institute
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Serenity GROUP
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).
Behavioral: Sernity intervention
Serenity Therapy is a holistic intervention that boosts psychological well-being and emotional balance through relaxation techniques, mindfulness, and guided imagery
No Intervention: Control group
The control group received only the routine care provided at the dialysis unit with no extra interventions.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Hemodialysis Symptoms Distress-22 scale
Time Frame: 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.
3 months
Coping Orientation to Problems Experienced Inventory
Time Frame: 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.
3 months
The Emotion Regulation Questionnaire
Time Frame: 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).
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Alexandria University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2024

Primary Completion (Estimated)

April 1, 2024

Study Completion (Estimated)

April 15, 2024

Study Registration Dates

First Submitted

February 4, 2024

First Submitted That Met QC Criteria

February 4, 2024

First Posted (Estimated)

February 13, 2024

Study Record Updates

Last Update Posted (Estimated)

February 13, 2024

Last Update Submitted That Met QC Criteria

February 4, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Other Study ID Numbers

  • 93/2024

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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