Effect of Su-Man Formula Massage Oil Acupressure on Sleep Quality and Anxiety in Patients With Insomnia

NCT04188340 | Completed

• 1 other identifier: CMUH107-REC1-031
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 1

Brief Summary

The present study predict that Su-Man formula massage oil acupressure can improved sleep quality.

Conditions

Insomnia

Keywords

Su-Man formula massage oil; Acupressure; Meridian energy; Insomnia

Outcome Measures

Primary Outcomes (1)

• Chinese version of Pittsburgh Sleep Quality Index

  Evaluate the sleep quaility of participants

  5mins

Secondary Outcomes (3)

• M.E.A.D (Meridian Energy Analysis Device)

  10mins

• Chinese version of Insomnia Severity Index

  5mins

• Chinese version of Beck Anxiety Inventory

  5mins

Study Arms (2)

control group

PLACEBO COMPARATOR

using bergamot massage oil apply to GV20, GV24 SP6, HT7 and PC6 acupoints, and massage for 20 times before sleep continuously 28 days

Behavioral: Su-Man formula massage oil

test group

EXPERIMENTAL

using Su-Man formula massage oil ap-ply to GV20, GV24, SP6, HT7 and PC6 acupoints, and massage for 20 times before sleep continuously 28 days

Behavioral: Su-Man formula massage oil

Interventions

Su-Man formula massage oil BEHAVIORAL

bergamot massage oil:dilute bergamot essential oil(0.5%) with almond oil Su-Man formula massage oil: mixed 4 different essential oil include bergamot, red mandarin, petit grain bigarade, spikenard and diluted with almond oil 5%.

Also known as: bergamot massage oil

control group; test group

Eligibility Criteria

• Age: 20 Years - 50 Years
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Women who has poor sleep status attaining a score of 5 on the Chinese Pittsburgh Sleep Quality Index
• years

You may not qualify if:

• having asthma or any diseases involving notable organ damage (e.g., heart, lungs, liver, or kidney failure or severe olfactory dysfunction)
• being pregnant
• being breastfeeding
• have reached menopause
• taking any medicine for improving sleep or anxiolytic drugs
• be allergic to the oil that this study used.
• having skin problem over the applying area,
• having smoking and alchol drinking habit
• inability to participate in the full course of the intervention courses

Sponsors & Collaborators

• China Medical University Hospital: lead

Study Sites (1)

ZEN chinese medicine clinic

New Taipei City, 235, Taiwan

Location

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders

Condition Hierarchy (Ancestors)

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

Study Officials

• Ching-Liang Hsieh, PhD

  China Medical University, China

  PRINCIPAL INVESTIGATOR

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: SPONSOR

Model Details: Patients with insomnia divided into two groups, each group is 20 patients as follows: 1) control group, using sweet al mond o il apply to GV20, GV24 SP6 , HT7 and PC6 acupoints, and massage for 10 times before sleep continuously 28 days; 2) treatment group, using Su Man formula m assage oil apply to GV20, GV24 , SP6 , HT7 and PC6 acupoints, and massage for 10 times before sleep cont inu ously 28 days.

Study Record Dates

• First Submitted: May 14, 2018
• First Posted: December 5, 2019
• Study Start: April 18, 2018
• Primary Completion: April 2, 2019
• Study Completion: April 2, 2019
• Last Updated: December 5, 2019

Record last verified: 2019-12

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)