Auricular Acupressure for Perimenopausal Insomnia

Summary

This clinical trial aims to determine whether auricular Acupressure therapy can improve symptomatic insomnia in perimenopausal women.

Can ear acupressure therapy significantly improve sleep quality in perimenopausal women with insomnia? What medical issues or adverse reactions might participants experience during the treatment? Researchers will compare ear acupressure therapy with traditional treatments in a control group to assess its effectiveness and safety.

Participants will:

Receive auricular acupressure on Monday and Thursday, applying pressure for 3 consecutive days each week. This process will continue for 4 weeks, totaling 8 sessions.

Record assessment points as follows: Baseline (2 weeks before treatment to Week 0), mid-treatment (2 weeks after treatment begins), end of treatment (4 weeks after treatment begins), and follow-up (4 weeks after treatment ends) for primary and secondary outcome indicators. Eight weeks after treatment concludes, only the primary outcome indicator (Insomnia Severity Index) will be recorded.

This trial seeks to evaluate the potential benefits and safety profile of auricular acupressure therapy for managing insomnia in perimenopausal women.

Conditions

• Perimenopausal Insomnia

Interventions

BEHAVIORAL

Auricular point compression

Acupuncture Points: Endocrine, Sympathetic, Shenmen, Heart Procedure Instructions: Disinfect the areas with 75% alcohol as per standard precautions. Treatments use only ear patches without Vaccaria seeds applied to these specific acupuncture points. Treatment sessions occur every Monday and Thursday. On Mondays, left ears are patched for three continuous days. Then on Thursdays, qualified medical personnel will remove the patches from the left ear and apply new patches to the right ear for four consecutive days. Any replacements must be performed at the hospital by qualified staff; patients should not attempt to do this themselves. This procedure is repeated weekly over a span of four weeks, resulting in eight total applications. Importantly, patients in this group do not perform acupoint stimulation as part of their treatment.

BEHAVIORAL

No pressure on the ear point

Acupuncture Points: Endocrine, Sympathetic, Shenmen, Heart Procedure Instructions: Disinfect the areas with 75% alcohol as per standard precautions. Treatments use only ear patches without Vaccaria seeds applied to these specific acupuncture points. Treatment sessions occur every Monday and Thursday. On Mondays, left ears are patched for three continuous days. Then on Thursdays, qualified medical personnel will remove the patches from the left ear and apply new patches to the right ear for four consecutive days. Any replacements must be performed at the hospital by qualified staff; patients should not attempt to do this themselves. This procedure is repeated weekly over a span of four weeks, resulting in eight total applications. Importantly, patients in this group do not perform acupoint stimulation as part of their treatment.

Sponsors & Collaborators

• Howest

  collaborator UNKNOWN

• The First Affiliated Hospital of Zhejiang Chinese Medical University

  lead OTHER

Study Design

Allocation

NA

Purpose

TREATMENT

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

45 Years

Max Age

55 Years

Sex

FEMALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2025-06-01

Primary Completion

2026-12-30

Completion

2026-12-30

Countries

• China

Study Locations