An interventional study of Horticultural Therapy in End-Stage Renal Disease, Renal Dialysis and Acute Stress, sponsored by Ataturk University. Not yet recruiting. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-09-28.
Sponsored by Ataturk University · Not applicable, Interventional, and Health services research
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.
Study Design and Setting:
This single-center, randomized, controlled, parallel-group trial aims to examine the immediate effects of a single-session horticultural therapy intervention on acute stress markers in hemodialysis patients at the Bingöl State Hospital Hemodialysis Unit. To minimize circadian and seasonal variation in cortisol levels, all data collection and interventions are standardized during the summer months within an early morning window (08:00 AM - 09:00 AM) during non-dialysis interdialytic days.
Randomization and Blinding:
Eligible participants (N=80) are randomized in a 1:1 ratio into either the Horticultural Therapy Group (n=40) or the Control Group (n=40) using computer-generated variable block randomization. Allocation concealment is maintained using sequentially numbered, opaque, sealed envelopes. Due to the nature of the behavioral intervention, participants and interventionists cannot be blinded; however, laboratory personnel conducting the salivary cortisol ELISA assays and the statistician analyzing the dataset are blinded to group allocations.
Intervention vs. Control Condition:
Horticultural Therapy Group: Participants engage in a standardized 45-60 minute individual session consisting of soil preparation, planting, and watering selected summer-adapted plant species (Tagetes erecta, Celosia cristata, and Petunia grandiflora) under researcher supervision using a standardized checklist.
Control Group: Participants undergo standard care and remain in a quiet waiting area within the hospital campus for 45-60 minutes without engaging in horticultural activities to match the time frame between pre- and post-tests.
Outcome Measures and Procedures:
Salivary Cortisol: Saliva samples are collected via passive drool before and immediately (within 5 minutes) after the intervention/waiting period. Behavioral controls (restricting food, caffeine, smoking, and tooth brushing prior to sampling) are rigorously enforced. Cortisol concentration is analyzed using commercial ELISA kits in a single batch, with intra- and inter-assay variations kept under 10% and 15%, respectively.
Psychological Assessments: State Anxiety Scale (STAI-1) is administered pre- and post-test. Baseline depression (PHQ-9) and perceived social support (MSPSS) are assessed upon enrollment to serve as potential statistical covariates along with demographic and clinical variables.
Statistical Analysis:
Primary hypothesis testing will be conducted using Linear Mixed-Effects Models (LMM) with group, time, and group-by-time interaction as fixed effects, adjusting for baseline covariates (PHQ-9, MSPSS, sampling time, and dialysis parameters) to evaluate the net acute intervention effect
ClinicalTrials.gov (PRS) sistemindeki Eligibility Criteria alanına birebir yapıştırabileceğiniz İngilizce format ve Türkçe anlamı aşağıdadır: Sisteme Girilecek Metin (İngilizce Format)PlaintextInclusion Criteria:
Exclusion Criteria:
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
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.
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.
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)
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)
No study locations are listed for this record.
Plan to share: No — Individual participant data will not be publicly shared to ensure participant confidentiality and data privacy in accordance with local ethical approvals and institutional data protection regulations. De-identified aggregate data may be made available upon reasonable request to the corresponding author.
No publications or documents are linked to this record.
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Ataturk University