NCT07192783

Brief Summary

This study aims to determine the effects of lavender oil inhalation on anxiety, sleep quality, and blood pressure in patients with primary hypertension. The study is designed as a double-blind randomized controlled trial. The study population consists of patients presenting to the Cardiology Outpatient Clinic of Ardahan State Hospital. Participants are randomly assigned to an experimental group, which will receive a total of 12 lavender oil inhalations three times a week for one month, or to a control group, which will continue routine treatment and care. Data will be collected using the Hypertension Diagnostic Form, Beck Anxiety Inventory, and Pittsburgh Sleep Quality Index. Statistical analyses will be conducted to compare outcomes between the experimental and control groups.

Trial Health

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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jul 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 7, 2025

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

September 9, 2025

Completed
16 days until next milestone

First Posted

Study publicly available on registry

September 25, 2025

Completed
14 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 9, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 9, 2025

Completed
Last Updated

September 25, 2025

Status Verified

September 1, 2025

Enrollment Period

3 months

First QC Date

September 9, 2025

Last Update Submit

September 17, 2025

Conditions

Keywords

primary hypertensionanxietysleep qualityblood pressure

Outcome Measures

Primary Outcomes (2)

  • Anxiety

    Measured using the Beck Anxiety Inventory (BAI) at baseline, week 2, and week 4. Higher scores indicate higher anxiety.

    Baseline, Week 2, Week 4

  • Blood Pressure

    Measured using the Hypertension Diagnostic Form at baseline, week 2, and week 4. Includes systolic and diastolic measurements.

    Baseline, Week 2, Week 4

Secondary Outcomes (1)

  • Sleep quality

    Baseline, Week 2, Week 4

Study Arms (2)

experimental group

EXPERIMENTAL

Participants receive lavender oil inhalation three times per week for one month (total of 12 sessions) in addition to routine care for primary hypertension. Anxiety, sleep quality, and blood pressure are assessed before and after the intervention.

Other: Lavender

Routine care only

NO INTERVENTION

Participants in the control group continue their routine care and treatment for primary hypertension without receiving lavender oil inhalation. Anxiety, sleep quality, and blood pressure are assessed before and after the study period.

Interventions

Participants receive lavender oil inhalation three times per week for one month (total of 12 sessions) using a standardized diffuser. This intervention is provided in addition to routine care for primary hypertension. Outcomes measured include anxiety, sleep quality, and blood pressure before and after the intervention.

experimental group

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Diagnosed with primary hypertension
  • Willing to participate in the study
  • No allergy to lavender
  • No olfactory impairments
  • No history of psychiatric disorders

You may not qualify if:

  • Communication difficulties
  • Unwilling to participate
  • Using other herbal or aromatherapy treatments
  • History of sleep disorders affecting sleep quality (e.g., obstructive sleep apnea)
  • Secondary hypertension or other chronic diseases
  • Pregnant or breastfeeding
  • Use of tobacco products

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ardahan State Hospital

Ardahan, Ardahan, 75000, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Essential HypertensionAnxiety DisordersSleep Initiation and Maintenance Disorders

Interventions

lavender oil

Condition Hierarchy (Ancestors)

HypertensionVascular DiseasesCardiovascular DiseasesMental DisordersSleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System Diseases

Central Study Contacts

Derya ŞİMŞEKLİ, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
Participants, the interventionist, and the statistician are blinded. Patients are randomly assigned using simple randomization (odd-numbered to one group, even-numbered to the other). Group allocation (lavender oil or control) is determined by an independent nurse. Separate consent forms and coded data entry (groups as 1 and 2) ensure blinding is maintained.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: The study uses a parallel assignment design with two groups: an experimental group receiving lavender oil inhalation and a control group receiving routine care. Participants are randomly assigned to one of the two groups. The study is double-blinded: neither the participants, the researchers administering the intervention, nor the statisticians analyzing the data know group assignments. Outcomes (anxiety, sleep quality, and blood pressure) are measured before and after the one-month intervention period.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Asist. Prof. Dr.

Study Record Dates

First Submitted

September 9, 2025

First Posted

September 25, 2025

Study Start

July 7, 2025

Primary Completion

October 9, 2025

Study Completion

October 9, 2025

Last Updated

September 25, 2025

Record last verified: 2025-09

Data Sharing

IPD Sharing
Will not share

Individual participant data will not be shared due to confidentiality and privacy concerns of study participants.

Locations