The Effectiveness of Auricular Acupressure on Sleep Quality, Mood Status, and Quality of Life

NCT05654155 | Completed DMC

• 1 other identifier: CMRPF1H0081
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

Brief Summary

This pilot study aimed to determine the feasibility and effectiveness of an auricular acupressure intervention on sleep, mood state, and QOL among parents of children with cancer.

Conditions

Parents of Children With Cancer

Keywords

sleep quality; quality of life; auricular acupressure

Outcome Measures

Primary Outcomes (4)

• Sleep Quality at baseline

  The Pittsburgh Sleep Quality Index (PSQI) is a validated multidimensional measure that assesses individuals' sleep quality.

  Data were collected before auricular acupressure intervention

• Sleep Quality at week 1

  The Pittsburgh Sleep Quality Index (PSQI) is a validated multidimensional measure that assesses individuals' sleep quality.

  Data were collected in the first week after completing 5 days of auricular acupressure.

• Sleep Quality at week 2

  The Pittsburgh Sleep Quality Index (PSQI) is a validated multidimensional measure that assesses individuals' sleep quality.

  Data were collected in the second week after auricular acupressure interventtion.

• Sleep Quality at week 3

  The Pittsburgh Sleep Quality Index (PSQI) is a validated multidimensional measure that assesses individuals' sleep quality.

  Data were collected in the 3rd week after auricular acupressure interventtion.

Secondary Outcomes (8)

• Mood State at baseline

  Data were collected before auricular acupressure intervention

• Mood State at week 1

  Data were collected in the first week after completing 5 days of auricular acupressure.

• Mood State at week 2

  Data were collected in the second week after auricular acupressure interventtion.

• Mood State at week 3

  Data were collected in the 3rd week after auricular acupressure interventtion.

• Quality of Life Short-Form at baseline

  Data were collected before auricular acupressure intervention

Study Arms (2)

Auricular acupressure group

EXPERIMENTAL

The AAG participants received auricular acupressure three times a day for five days every week for three weeks. Using Dr. Huang's ear reflex theory, our AAG intervention included six acupoints (i.e., shenmen, subcortex, heart, kidney, anxious, and neurasthenia points) that have been demonstrated to be effective in improving sleep and emotional stability.

Other: auricular acupressure

sham auricular acupressure group

SHAM COMPARATOR

Participants in SAG received the same protocol of auricular acupressure as the AAG, but six acupoints were used near the treated acupoints (e.g., sacroiliac, neck, stomach, wrist, tonsil, and tongue), which would have had no effects on participants' sleep and mood status.

Other: auricular acupressure

Interventions

auricular acupressure OTHER

Auricular acupressure therapy is a well-established treatment strategy whose foundations lie in Traditional Chinese Medicine and is a therapy that is increasingly used in Western medicine.

Auricular acupressure group; sham auricular acupressure group

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Parent of a child (less than 18 years old) who was newly diagnosed with cancer (less than 3 months).
• parent of a child and who was receiving treatment with chemotherapy Must be able to swallow tablets

You may not qualify if:

• Parents were receiving any medication or treatment for insomnia.
• Parents had received any acupuncture or acupressure in the recent 3 months.
• Parents had ever been diagnosed with other chronic illnesses (such as cancer, heart disease, or asthma) at the time of data collection.

Sponsors & Collaborators

• Chang Gung University of Science and Technology: lead
• Chang Gung Memorial Hospital: collaborator

Study Sites (1)

Yi-Chien Chiang

Taoyuan District, Taoyuan City, 33303, Taiwan

Location

Related Publications (1)

• Chiang YC, Chen SH, Moser DK, Wen YC, Lin YT, Hsiao YC. Effectiveness of auricular acupressure in managing sleep quality, mood, and quality of life in parents of children with cancer: A pilot randomized controlled trial. Asia Pac J Oncol Nurs. 2024 Sep 25;11(11):100601. doi: 10.1016/j.apjon.2024.100601. eCollection 2024 Nov.

  PMID: 39582551 DERIVED

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

• Yi-Chien Chiang, PhD

  Chang Gung University of Science and Technology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor

Model Details: The auricular acupressure group (AAG) participants received auricular acupressure three times a day for five days every week for three weeks. Using Dr. Huang's ear reflex theory, our AAG intervention included six acupoints (i.e., shenmen, subcortex, heart, kidney, anxious, and neurasthenia points) that have been demonstrated to be effective in improving sleep and emotional stability. Participants in SAG (sham auricular acupressure group) received the same protocol of auricular acupressure as the AAG, but six acupoints were used near the treated acupoints (e.g., sacroiliac, neck, stomach, wrist, tonsil, and tongue), which would have had no effects on participants' sleep and mood status.

Study Record Dates

• First Submitted: November 10, 2022
• First Posted: December 16, 2022
• Study Start: November 30, 2019
• Primary Completion: November 30, 2020
• Study Completion: November 30, 2020
• Last Updated: December 16, 2022

Record last verified: 2022-12

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)