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

NCT06255184 | Recruiting DMC

• 1 other identifier: 93/2024
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 2

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.

Conditions

Geriatric Patients

Outcome Measures

Primary Outcomes (3)

• 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

• 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

• 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

Study Arms (2)

Serenity GROUP

EXPERIMENTAL

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

Control group

NO INTERVENTION

The control group received only the routine care provided at the dialysis unit with no extra interventions.

Interventions

Sernity intervention BEHAVIORAL

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

Serenity GROUP

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Alexandria University: lead

Study Sites (2)

Hemodialysis unit of the National Medical Institute

Damanhur, El-Behaira Governorate, Egypt., Egypt

RECRUITING

Faculty of Nursing, Alexandria university

Alexandria, Egypt

RECRUITING

Related Publications (1)

• Abd El Fatah NK, Khedr MA, Elzohairy NW, Harfoush MS, Elgarhy SMA. Effect of serenity therapy on symptoms distress, coping styles, and emotional regulation among geriatric patients undergoing hemodialysis: A randomized controlled trial. Geriatr Nurs. 2026 Jan 21;69:103863. doi: 10.1016/j.gerinurse.2026.103863. Online ahead of print.

  PMID: 41570623 DERIVED

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer

Study Record Dates

• First Submitted: February 4, 2024
• First Posted: February 13, 2024
• Study Start: January 1, 2024
• Primary Completion: April 1, 2024
• Study Completion: April 15, 2024
• Last Updated: February 13, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

EG (2)