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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06255184
Other study ID # 93/2024
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date January 1, 2024
Est. completion date April 15, 2024

Study information

Verified date February 2024
Source Alexandria University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 80
Est. completion date April 15, 2024
Est. primary completion date April 1, 2024
Accepts healthy volunteers No
Gender All
Age group 60 Years and older
Eligibility 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


Related Conditions & MeSH terms


Intervention

Behavioral:
Sernity intervention
Serenity Therapy is a holistic intervention that boosts psychological well-being and emotional balance through relaxation techniques, mindfulness, and guided imagery

Locations

Country Name City State
Egypt Faculty of Nursing, Alexandria university Alexandria
Egypt Hemodialysis unit of the National Medical Institute Damanhur El-Behaira Governorate, Egypt.

Sponsors (1)

Lead Sponsor Collaborator
Alexandria University

Country where clinical trial is conducted

Egypt, 

Outcome

Type Measure Description Time frame Safety issue
Primary Hemodialysis Symptoms Distress-22 scale 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
Primary Coping Orientation to Problems Experienced Inventory 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
Primary The Emotion Regulation Questionnaire 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
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