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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

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07373132
Enrollment
64
Registered
2026-01-28
Start date
2026-05-01
Completion date
2027-01-31
Last updated
2026-05-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Insomnia

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.

Interventions

OTHERAromatherapy

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.

OTHERPlacebo

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

Sponsors

The Second Hospital of Anhui Medical University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Intervention model description

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

Eligibility

Sex/Gender
FEMALE
Age
60 Years to 100 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Athens Insomnia ScaleEvaluated at baseline, day 6 and 2-week follow-up.Total score 0-24; higher scores indicate worse insomnia.

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: May 28, 2026