EFFECTS OF HORTICULTURAL THERAPY ON ACUTE STRESS AND SALIVARY CORTISOL LEVELS IN HEMODIALYSIS PATIENTS

NCT07845214 | Not Yet Recruiting

• 1 other identifier: xxxxxxx
• Study Type: interventional
• Target: 80
• Locations: 0 countries
• Sites: N/A

Brief Summary

The purpose of this study is to evaluate the acute psychological and physiological effects of a single-session structured horticultural therapy program on patients undergoing routine hemodialysis. The study is designed as a two-arm, parallel, pretest-posttest randomized controlled trial conducted at Bingöl State Hospital. Participants are randomized (1:1) to either an experimental group receiving a 45-60 minute individual horticultural therapy session (e.g., planting and caring for Tagetes erecta, Celosia cristata, and Petunia grandiflora) or a control group maintaining standard waiting conditions for the same duration during non-dialysis days. Primary outcomes evaluate acute changes in state anxiety (measured via STAI-1) and physiological stress response (measured via salivary cortisol concentration) before and immediately after the intervention.

Conditions

End-Stage Renal Disease; Renal Dialysis; Acute Stress

Keywords

Horticultural Therapy; Salivary Cortisol; Hemodialysis; Complementary Therapies; Psychological Stress

Outcome Measures

Primary Outcomes (1)

• Change in Salivary Cortisol Levels

  Salivary cortisol concentrations measured via ELISA assay (expressed in nmol/L) to evaluate the acute physiological stress response. Samples are collected via passive drool. The primary outcome is the net change from baseline to post-intervention between groups.

  Baseline (immediately before intervention) and Post-test (within 5 minutes immediately following the 45-60 minute intervention/waiting period)

Secondary Outcomes (1)

• Change in State Anxiety Scores

  Baseline (immediately before intervention) and Post-test (immediately following the 45-60 minute intervention/waiting period)

Study Arms (2)

Horticultural Therapy Group

EXPERIMENTAL

Participants in this arm receive a single-session, structured horticultural therapy intervention lasting 45-60 minutes on a non-dialysis day. The intervention includes guided soil preparation, planting, and watering of selected summer-adapted flowering plants (Tagetes erecta, Celosia cristata, Petunia grandiflora) under researcher supervision using a standardized checklist.

Behavioral: Horticultural Therapy

Control Group

NO INTERVENTION

Participants in this arm receive routine hemodialysis care without any horticultural therapy intervention. To match the time frame between pre- and post-test measurements with the experimental group, participants remain in a quiet waiting area within the hospital campus for 45-60 minutes under standard waiting conditions on a non-dialysis day.

Interventions

Horticultural Therapy BEHAVIORAL

A structured, single-session individual horticultural therapy intervention lasting 45-60 minutes conducted on a non-dialysis day in an outdoor/indoor setting at the hospital campus. Under the guidance of the researcher and following a standardized checklist, participants engage in active hands-on gardening activities using summer-adapted flowering plants (Tagetes erecta, Celosia cristata, Petunia grandiflora). The protocol includes soil preparation, planting seedlings into pots/beds, supporting roots, and initial watering to provide tactile and visual sensory stimulation.

Horticultural Therapy 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:

• Age between 18 and 65 years
• Receiving maintenance hemodialysis treatment for at least 6 months
• Receiving hemodialysis 3 times a week, 4 hours per session
• Cognitive ability to comprehend and complete study questionnaires
• Willingness to participate in the study and signing the informed consent form

You may not qualify if:

• Severe physical, motor, or visual impairment preventing participation in horticultural activities
• Active acute infection or severe systemic disease flare
• Current use of systemic corticosteroid therapy or medications significantly altering cortisol metabolism
• Severe psychiatric illness or cognitive impairment (e.g., dementia) diagnosed by a physician
• Regular participation in any formal complementary/alternative therapy or plant-ca

Sponsors & Collaborators

• Bingol University: collaborator
• Ataturk University: lead

MeSH Terms

Conditions

Kidney Failure, Chronic; Stress, Psychological

Interventions

Horticultural Therapy

Condition Hierarchy (Ancestors)

Renal Insufficiency, Chronic; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Complementary Therapies; Therapeutics; Psychotherapy; Behavioral Disciplines and Activities

Central Study Contacts

Mahmut Çoban, PhD, RN

CONTACT

05387022343; mahmutcoban@bingol.edu.tr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Laboratory personnel performing the salivary cortisol ELISA assays and the statistician conducting the data analysis are blinded to group allocations. All biological samples and dataset records are coded using unique identification numbers to maintain blinding throughout the evaluation process.
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor, PhD

Model Details: Participants are randomly assigned in a 1:1 ratio to either the horticultural therapy intervention group or the control group using computer-generated variable block randomization. Both groups are evaluated simultaneously in a parallel design with pre- and post-test measurements during the same interdialytic period.

Study Record Dates

• First Submitted: September 22, 2026
• First Posted: September 28, 2026
• Study Start (Estimated): October 15, 2026
• Primary Completion (Estimated): November 15, 2026
• Study Completion (Estimated): November 30, 2026
• Last Updated: September 28, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share