End-Stage Renal DiseaseNCT07845214
EFFECTS OF HORTICULTURAL THERAPY ON ACUTE STRESS AND SALIVARY CORTISOL LEVELS IN HEMODIALYSIS PATIENTS
A study testing Horticultural Therapy in people with End-Stage Renal Disease and Renal Dialysis, run by Ataturk University.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- End-Stage Renal Disease, Renal Dialysis, Acute Stress
- What is being tested?
- Horticultural Therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- No sites listed yet
- Study dates
- 15 Oct 2026to 30 Nov 2026
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- 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
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: THE EFFECT OF HORTICULTURAL THERAPY APPLIED TO HEMODIALYSIS PATIENTS ON ACUTE STRESS AND SALIVARY CORTISOL LEVELS: A RANDOMIZED CONTROLLED 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.
Read the 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
- Conditions
- End-Stage Renal Disease, Renal Dialysis, Acute Stress
- Being tested
- Horticultural Therapy
- Keywords
- Horticultural Therapy, Salivary Cortisol, Hemodialysis, Complementary Therapies, Psychological Stress
- Medical subject headings
- Kidney Failure, Chronic, Stress, Psychological
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Horticultural TherapyBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Baseline (immediately before intervention) and Post-test (immediately following the 45-60 minute intervention/waiting period)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2026
- Study start15 Oct 2026 (estimated)
- Primary completion15 Nov 2026 (estimated)
- Study completion30 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for End-Stage Renal DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ataturk University
- Sponsor type
- University, hospital or other
- Collaborators
- Bingol University
- Responsible party
- Principal investigator, Mahmut Coban, Ataturk University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07845214
- Sponsor's protocol ID
- xxxxxxx
- Status last verified
- Sep 2026
- First submitted
- 22 Sep 2026
- Last updated
- 28 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.