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

NCT07373132 | Not Yet Recruiting

• 1 other identifier: ZWei
• Study Type: interventional
• Target: 64
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Insomnia

Outcome Measures

Primary Outcomes (1)

• Athens Insomnia Scale

  Total score 0-24; higher scores indicate worse insomnia.

  Evaluated at baseline, day 6 and 2-week follow-up.

Study Arms (2)

aromatherapy

EXPERIMENTAL

Other: Aromatherapy

placebo

PLACEBO COMPARATOR

Other: Placebo

Interventions

Aromatherapy OTHER

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.

aromatherapy

Placebo OTHER

Identical procedure using odorless fractionated coconut oil. Sham acupoint pressure on a non-acupoint location near the wrist performed identically to maintain blinding.

placebo

Eligibility Criteria

• Age: 60 Years - 100 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• The Second Hospital of Anhui Medical University: lead

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders

Interventions

Aromatherapy

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Intervention Hierarchy (Ancestors)

Mind-Body Therapies; Complementary Therapies; Therapeutics; Phytotherapy; Sensory Art Therapies; Psychotherapy; Behavioral Disciplines and Activities

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Model Details: Participants will be randomly allocated to receive either standardized aromatherapy (lavender essential oil) or placebo (odorless fractionated coconut oil) for five consecutive nights

Study Record Dates

• First Submitted: January 10, 2026
• First Posted: January 28, 2026
• Study Start: February 1, 2026
• Primary Completion (Estimated): January 31, 2027
• Study Completion (Estimated): January 31, 2027
• Last Updated: January 28, 2026

Record last verified: 2026-01