EFFECTS OF HORTICULTURAL THERAPY ON ACUTE STRESS AND SALIVARY CORTISOL LEVELS IN HEMODIALYSIS PATIENTS
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorAtaturk University
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Horticultural Therapy
BehavioralA 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.
Treatment groups
80 Participants
are divided into 2 treatment groupsGroup A: Horticultural Therapy GroupExperimental treatment 1 intervention
Group B: Control GroupNo intervention 0 interventions
Trial outcomes
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.
Time frame
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
Psychological state anxiety evaluated using the State-Trait Anxiety Inventory - State Form (STAI-1). Total scores range from 20 to 80, with higher scores indicating higher levels of perceived acute state anxiety.
Time frame
Baseline (immediately before intervention) and Post-test (immediately following the 45-60 minute intervention/waiting period)Locations
Sponsors and contacts
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Ataturk University
Lead sponsor
Bingol University
Collaborator
Source ClinicalTrials.gov
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