Effect of Lavender on Sleep Quality and Insomnia Severity in Patients

NCT06778876 | Completed

• 1 other identifier: SBU-RSH-BDA-01
• Study Type: interventional
• Target: 68
• Locations: 1 country
• Sites: 1

Brief Summary

Today, psychophysiological insomnia is the most common persistent insomnia. Lavender essential oil is frequently used in the literature as an aromatherapy method to improve sleep quality. Studies have found that lavender improves sleep quality. They also emphasized that more studies are needed in this area. When the relevant literature is reviewed, no studies examining the effects of lavender oil on patients with psychophysiological insomnia were found. In this context, the aim of the study was to evaluate the effect of lavender on sleep quality and insomnia severity in patients with psychophysiological insomnia.

Conditions

Insomnia, Psychophysiological

Keywords

insomnia; sleep quality; Sleepiness; Lavender

Outcome Measures

Primary Outcomes (1)

• The Pittsburgh Sleep Quality Index

  PSQI is a 19-item scale, assessed by self-report (19 items) and spouse/roommate responses (5 items). The scale includes components such as sleep quality, duration, and disturbance, and the total score ranges from 0 to 21; a score greater than 5 indicates poor sleep quality.

  two weeks

Secondary Outcomes (2)

• The Insomnia Severity Index

  two weeks

• The Epworth Sleepiness Scale

  two weeks

Study Arms (2)

lavender sachet group

ACTIVE COMPARATOR

The normal procedure applied in the sleep clinic (keeping a sleep diary, sleep hygiene education) will be followed and participants will be asked to sleep with lavender sachets inside their pillows for two weeks.

Other: lavender sachet group

Control group

SHAM COMPARATOR

Participants will follow the normal procedure applied (keeping a sleep diary, sleep hygiene training) in the sleep clinic and no additional intervention will be performed.

Other: control group

Interventions

lavender sachet group OTHER

The normal procedure applied in the sleep clinic (keeping a sleep diary, sleep hygiene education) will be followed and participants will be asked to sleep with lavender sachets inside their pillows for two weeks.

lavender sachet group

control group OTHER

Participants will follow the normal procedure applied (keeping a sleep diary, sleep hygiene training) in the sleep clinic and no additional intervention will be performed.

Control group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Being 18 years of age or older,
• Being over 65 years old
• Being diagnosed with psychophysiological insomnia,
• Knowing Turkish at a level that will allow you to read and understand the survey questions,
• Accepting to participate in the study

You may not qualify if:

• Having a serious physical or cognitive disability that would prevent him/her from answering the survey,
• Being under the age of 18,
• Not accepting to participate in the study,
• Being allergic to lavender,
• Having a chronic additional disease related to the respiratory system,
• Having a psychiatric or neurological additional disease,
• Using medication(s) that may affect sleep,
• Experiencing a physical activity limitation that causes bedriddenness,
• Having or contracting a disease that will affect the ability to smell.

Sponsors & Collaborators

• Saglik Bilimleri Universitesi Gulhane Tip Fakultesi: lead

Study Sites (1)

University of Health Sciences

Ankara, Keçiören, 06010, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders; Sleepiness

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Officials

• Bülent D. Akçay, Assoc. Prof.

  Saglik Bilimleri Universitesi

  PRINCIPAL INVESTIGATOR

• Mehmet Koçer, MD

  Gulhane Training and Research Hospital

  PRINCIPAL INVESTIGATOR

• Duygu Akçay, Asst.Prof

  Ufuk University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: participants and outcome assessors will not be informed about group assignments and will be blinded.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: University of Health Sciences

Model Details: two groups with a control group.

Study Record Dates

• First Submitted: January 12, 2025
• First Posted: January 16, 2025
• Study Start: January 21, 2025
• Primary Completion: July 21, 2025
• Study Completion: September 12, 2025
• Last Updated: September 16, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)