End-Stage Renal Disease, Renal Dialysis, Acute Stress
Conditions
Keywords
Horticultural Therapy, Salivary Cortisol, Hemodialysis, Complementary Therapies, Psychological Stress
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.
Detailed description
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
Interventions
BEHAVIORALHorticultural Therapy
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.
Sponsors
Ataturk University
Bingol University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE (Outcomes Assessor)
Masking description
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.
Intervention model description
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
ClinicalTrials.gov (PRS) sistemindeki Eligibility Criteria alanına birebir yapıştırabileceğiniz İngilizce format ve Türkçe anlamı aşağıdadır: Sisteme Girilecek Metin (İngilizce Format)PlaintextInclusion Criteria: * 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
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Salivary Cortisol Levels | Baseline (immediately before intervention) and Post-test (within 5 minutes immediately following the 45-60 minute intervention/waiting period) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in State Anxiety Scores | Baseline (immediately before intervention) and Post-test (immediately following the 45-60 minute intervention/waiting period) | 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. |
Contacts
CONTACTMahmut Çoban, PhD, RN
Outcome results
None listed