Effects of Aromatherapy on Sleep Quality in Hospitalized Elderly Female Patients With Insomnia

Effects of Aromatherapy on Sleep Quality in Hospitalized Elderly Female Patients With Insomnia: Protocol for A Randomized, Double-Blind, Placebo-Controlled Parallel Trial

To evaluate the efficacy and safety of standardized aromatherapy compared with placebo in improving sleep quality among hospitalized elderly female patients with insomnia.

Study Overview

• Status: Not yet recruiting
• Conditions: Insomnia
• Intervention / Treatment: Other: Aromatherapy; Other: Placebo

• Study Type: Interventional
• Enrollment (Estimated): 64
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Female, aged ≥60 years.
• Hospitalized in the Second Affiliated Hospital of Anhui Medical University.
• Athens Insomnia Scale (AIS) >6.
• Ability to communicate and understand instructions.
• Non-allergic to essential oils.
• Fully informed and voluntarily consent to participate.

Exclusion Criteria:

• Cognitive impairment-.
• History of hypersensitivity to aromatherapy oils.
• Use of sedative-hypnotic medications within past 2 weeks.
• Sleep disorders secondary to organic or psychiatric diseases.
• Unable to comply with study procedures.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: placebo	Other: Placebo; Identical procedure using odorless fractionated coconut oil. Sham acupoint pressure on a non-acupoint location near the wrist performed identically to maintain blinding.
Experimental: aromatherapy	Other: Aromatherapy; Verify patient identity and explain the intervention. Ensure comfortable supine or semi-recumbent position. Drop 2 drops of lavender essential oil onto a sterile cotton ball; place inside disposable urine cup. Position cup 20 cm from patient's nostrils; instruct patient to perform 10 deep breaths. Place cup at bedside until morning. Lay treatment cloth under patient's wrists. Apply 1 drop of lavender oil to both thumbs, perform bilateral Shenmen (HT7) acupoint pressure on the wrist Shenmen acupoint pressure for 10 minutes per side, moderate pressure causing mild local distension but no pain. Restore patient to comfortable position; remove materials; wash hands. Record any immediate reactions or discomfort.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Athens Insomnia Scale	Total score 0-24; higher scores indicate worse insomnia.	Evaluated at baseline, day 6 and 2-week follow-up.

Collaborators and Investigators

• Sponsor: The Second Hospital of Anhui Medical University

Study record dates

Study Major Dates

• Study Start (Estimated): May 1, 2026
• Primary Completion (Estimated): January 31, 2027
• Study Completion (Estimated): January 31, 2027

Study Registration Dates

• First Submitted: January 10, 2026
• First Submitted That Met QC Criteria: January 22, 2026
• First Posted (Actual): January 28, 2026

Study Record Updates

• Last Update Posted (Actual): May 27, 2026
• Last Update Submitted That Met QC Criteria: May 25, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Mental Disorders; Sleep Wake Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Initiation and Maintenance Disorders; Therapeutics; Mind-Body Therapies; Complementary Therapies; Psychotherapy; Behavioral Disciplines and Activities; Sensory Art Therapies; Phytotherapy; Aromatherapy
• Other Study ID Numbers: ZWei

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No