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Not yet recruiting NCT07373132

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

No phase Interventional Insomnia

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Aromatherapy, Placebo.
Who it may be relevant to
Registry conditions: Insomnia. Basic parameters: 60 years — 100 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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

Interventions

  • 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 acu
  • 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.

Primary outcome measures

  • Athens Insomnia Scale [Time frame: Evaluated at baseline, day 6 and 2-week follow-up.]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Quadruple blind
Primary purpose
Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07373132 · ZWei

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗