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

NCT ID: NCT05654155

Last Updated: 2022-12-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

35 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-11-30

Study Completion Date

2020-11-30

Brief Summary

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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.

Detailed Description

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This was a feasibility pilot study conducted using a randomized controlled design in which participants were randomly assigned to either an active auricular acupressure group (AAG) or a sham auricular acupressure group (SAG). Data were collected at baseline (time 0), and 1-week (time 1), 2-weeks (time 2) and 3-weeks (time 3) after the end of the intervention, which was 3 weeks long.

Participants To be included in the study, participants needed to be a parent of a child (less than 18 years old) who was newly diagnosed with cancer (less than 3 months) and who was receiving treatment with chemotherapy. Parents were excluded if they were: (1) receiving any medication or treatment for insomnia; (2) had received any acupuncture or acupressure in the recent 3 months; or (3) had ever been diagnosed with other chronic illnesses (such as cancer, heart disease, or asthma) at the time of data collection. The reason for excluding parents with chronic illnesses was to increase the similarity of subjects in this study, because such chronic illnesses may have an impact on sleep and mood.

Intervention: auricular acupressure program 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 17, 18. 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.

Both acupressure interventions were started by cleaning the earlobe using 75% alcohol. Then, a small piece of adhesive tape with 2 seeds, which provide pressure at specific points was taped onto each selected auricular acupoint on a participant's ear. Next, the auricular therapist demonstrated the acupoints press technique to participants. The participants were asked to press one acupoint slightly to more firmly for 1 minute by themselves until they felt discomfort or tingling, then move to the next acupoint until all 6 acupoints were completed. The ear seed tapes were kept in place for 5 days and removed by participants for 2 days. After the 2-day rest period, the participant returned to the researcher to have the ear tapes replaced. Unilateral auricular points were used for the intervention and the treatment ear was changed to the other ear every week until the 3-week intervention was completed. All the auricular acupressure interventions were conducted by the same researcher.

Conditions

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Parents of Children With Cancer

Keywords

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sleep quality quality of life auricular acupressure

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.
Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Auricular acupressure group

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.

Group Type EXPERIMENTAL

auricular acupressure

Intervention Type 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.

sham auricular acupressure group

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.

Group Type SHAM_COMPARATOR

auricular acupressure

Intervention Type 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.

Interventions

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auricular acupressure

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.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* 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.
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Chang Gung Memorial Hospital

OTHER

Sponsor Role collaborator

Chang Gung University of Science and Technology

OTHER

Sponsor Role lead

Responsible Party

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Yi-Chien Chiang

Associate professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Yi-Chien Chiang, PhD

Role: PRINCIPAL_INVESTIGATOR

Chang Gung University of Science and Technology

Locations

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Yi-Chien Chiang

Taoyuan District, Taoyuan City, Taiwan

Site Status

Countries

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Taiwan

References

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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.

Reference Type DERIVED
PMID: 39582551 (View on PubMed)

Other Identifiers

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CMRPF1H0081

Identifier Type: -

Identifier Source: org_study_id