The Effect of Horticultural Therapy on Stress, Well-Being, and Care Burden in Hemodialysis Caregivers

NCT07188792 | Active Not Recruiting

• 1 other identifier: B.30.2.ATA.0.01.00/210 -63
• Study Type: interventional
• Target: 82
• Locations: 1 country
• Sites: 1

Brief Summary

This research is a randomized controlled single-blind experimental study aiming to evaluate the effect of horticultural therapy on stress, well-being, and caregiver burden among caregivers of hemodialysis patients. The study will be conducted between April-July 2025 with caregivers of patients receiving hemodialysis treatment at Bingöl State Hospital. The sample of the study will consist of 82 caregivers, randomly assigned into experimental and control groups. After obtaining verbal and written consents from all participants, the Introductory Information Form, Perceived Stress Scale, General Well-Being Scale, and Zarit Burden Interview will be applied as pre-test. The experimental group will participate in horticultural therapy activities once a week for 12 weeks, while no intervention will be given to the control group during this period. Following the intervention, post-test measurements will be administered to both groups using the same instruments. In addition, feedback will be collected from caregivers in the experimental group regarding the research process. After the study is completed, the same intervention will also be offered to the control group to ensure ethical responsibility. Data obtained will be analyzed using SPSS 22.00 package program. Ethical principles will be observed throughout the study, ethics committee approval has been obtained, and the Helsinki Declaration of Human Rights will be adhered to. The results are planned to be presented at an international congress and published in an SCI/SSCI-indexed journal, contributing to the scientific literature.

Conditions

Hemodialysis Patients

Keywords

perceived stress; caring; maintenance burden; hemodialysis patient; horticultural therapy

Outcome Measures

Primary Outcomes (1)

• Caregiver Introduction Form

  This form was prepared by researchers based on literature. It consists of 16 questions covering the sociodemographic characteristics of caregivers (age, gender, family type, marital status, number of children, number of family members, occupation, economic status, education level, place of residence, number of years the patient has been receiving dialysis treatment, degree of closeness to the caregiver, length of caregiving, duration of daily caregiving, other caregivers in the family, and presence or absence of chronic illness).

  baseline

Secondary Outcomes (1)

• Perceived Stress Scale

  at the beginning and at the end of the 12-week study

Other Outcomes (2)

• General Well-Being Scale

  at baseline and at the end of the 12-week study

• Zarit Caregiving Burden Scale

  at baseline and at the end of the 12-week study

Study Arms (2)

EXPERIMENTAL GROUP

EXPERIMENTAL

The Caregiver Identification Form, Perceived Stress Scale, General Well-Being Scale and Zarit Caregiver Burden Scale were applied to the experimental and control groups. In the study, horticultural activities prepared with literature support and expert opinions as a nursing intervention were applied to the experimental group once a week for 12 weeks.

Other: HORTICULTURAL THERAPY

CONTROL GROUP

NO INTERVENTION

No ınterventıon was made to the control group durıng the study. After the gardening care activity in which the experimental system was applied, the Perceived Stress Scale, General Well-Being Scale and Zarit Caregiving Burden Scale were administered to the individuals in the experimental and control groups in order to measure the post-test data.

Interventions

HORTICULTURAL THERAPY OTHER

* Introduction * Explanation of the training content for horticultural activities using visual materials * Explanation of the program's scope, duration, and expected participant roles and responsibilities

EXPERIMENTAL GROUP

Eligibility Criteria

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

You may qualify if:

• Being the primary caregiver for a patient receiving treatment in a hemodialysis unit,
• Having provided active care for at least six months,
• Not having a physical condition that would prevent participation in horticultural activities,
• Not having a psychiatric illness,
• Being able to communicate and be open to collaboration,
• Having regularly attended at least 80% (nine) of the horticultural activity sessions.

You may not qualify if:

• Those with a physical illness that would prevent them from participating in gardening-based activities,
• Those with a psychiatric illness,
• Those whose caregiver may be transferred to another dialysis center along with their patient during the study period,
• Caregivers with no continuity of care.

Sponsors & Collaborators

• Ataturk University: lead

Study Sites (1)

Atatürk Üniverty

Erzurum, 25100, Turkey (Türkiye)

Location

MeSH Terms

Interventions

Horticultural Therapy

Intervention Hierarchy (Ancestors)

Complementary Therapies; Therapeutics; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• DİLEK KILIÇ

  Ataturk University

  PRINCIPAL INVESTIGATOR

• GÜLNAZ ATA

  TOKAT GAZİOSMANPAŞA UNIVERSITY

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Single blindness is achieved by not specifying which section is specified during the data collection process.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: lecturer

Model Details: The study population consisted of 120 caregivers receiving treatment in the hemodialysis unit at Bingöl State Hospital; the sample consisted of 82 caregivers who met the study criteria and agreed to participate in the study. The sample size for the study was calculated as 70 using the G\*Power 3.1 program, taking into account similar studies, a 5% effect size, 95% reliability, and 80% theoretical power. To prevent participants from withdrawing from the study at any stage, 12 more individuals (15% more than the sample size) were added to the predetermined sample, resulting in a total of 82 participants. Those who agreed to participate after obtaining verbal consent from these individuals were included in the sample. The caregiver assignment to the experimental or control groups was determined at the beginning of the study using the Random Allocation Software 1.0.0 package program.

Study Record Dates

• First Submitted: September 8, 2025
• First Posted: September 23, 2025
• Study Start: September 1, 2024
• Primary Completion: March 1, 2025
• Study Completion: October 1, 2025
• Last Updated: September 23, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)