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

Sponsor
Chang Gung University of Science and Technology (Other)
Overall Status
Completed
CT.gov ID
NCT05654155
Collaborator
Chang Gung Memorial Hospital (Other)
35
1
2
12
2.9

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: auricular acupressure
N/A

Detailed Description

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
35 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
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.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.
Masking:
Single (Participant)
Primary Purpose:
Treatment
Official Title:
A Pilot Study of the Feasibility and Effectiveness of Auricular Acupressure in Managing Sleep Quality, Mood Status, and Quality of Life in Parents of Children With Cancer
Actual Study Start Date :
Nov 30, 2019
Actual Primary Completion Date :
Nov 30, 2020
Actual Study Completion Date :
Nov 30, 2020

Arms and Interventions

Arm Intervention/Treatment
Experimental: 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.

Other: 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.

Sham Comparator: 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.

Other: 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.

Outcome Measures

Primary Outcome Measures

  1. Sleep Quality at baseline [Data were collected before auricular acupressure intervention]

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

  2. Sleep Quality at week 1 [Data were collected in the first week after completing 5 days of auricular acupressure.]

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

  3. Sleep Quality at week 2 [Data were collected in the second week after auricular acupressure interventtion.]

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

  4. Sleep Quality at week 3 [Data were collected in the 3rd week after auricular acupressure interventtion.]

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

Secondary Outcome Measures

  1. Mood State at baseline [Data were collected before auricular acupressure intervention]

    The Profile of Mood State (POMS) was developed to investigate individuals' mood status.

  2. Mood State at week 1 [Data were collected in the first week after completing 5 days of auricular acupressure.]

    The Profile of Mood State (POMS) was developed to investigate individuals' mood status.

  3. Mood State at week 2 [Data were collected in the second week after auricular acupressure interventtion.]

    The Profile of Mood State (POMS) was developed to investigate individuals' mood status.

  4. Mood State at week 3 [Data were collected in the 3rd week after auricular acupressure interventtion.]

    The Profile of Mood State (POMS) was developed to investigate individuals' mood status.

  5. Quality of Life Short-Form at baseline [Data were collected before auricular acupressure intervention]

    The Quality of Life Short-Form 36 (QOL-SF) was used to measure quality of life in parents of children with cancer for this study.

  6. Quality of Life Short-Form at week 1 [Data were collected in the first week after completing 5 days of auricular acupressure.]

    The Quality of Life Short-Form 36 (QOL-SF) was used to measure quality of life in parents of children with cancer for this study.

  7. Quality of Life Short-Form at week 2 [Data were collected in the second week after auricular acupressure interventtion.]

    The Quality of Life Short-Form 36 (QOL-SF) was used to measure quality of life in parents of children with cancer for this study.

  8. Quality of Life Short-Form at week 3 [Data were collected in the 3rd week after auricular acupressure interventtion.]

    The Quality of Life Short-Form 36 (QOL-SF) was used to measure quality of life in parents of children with cancer for this study.

Eligibility Criteria

Criteria

Ages Eligible for Study:
N/A and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Yi-Chien Chiang Taoyuan Taoyuan City Taiwan 33303

Sponsors and Collaborators

  • Chang Gung University of Science and Technology
  • Chang Gung Memorial Hospital

Investigators

  • Principal Investigator: Yi-Chien Chiang, PhD, Chang Gung University of Science and Technology

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Yi-Chien Chiang, Associate professor, Chang Gung University of Science and Technology
ClinicalTrials.gov Identifier:
NCT05654155
Other Study ID Numbers:
  • CMRPF1H0081
First Posted:
Dec 16, 2022
Last Update Posted:
Dec 16, 2022
Last Verified:
Dec 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Yi-Chien Chiang, Associate professor, Chang Gung University of Science and Technology

Study Results

No Results Posted as of Dec 16, 2022