- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05654155
The Effectiveness of Auricular Acupressure on Sleep Quality, Mood Status, and Quality of Life
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
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Taoyuan City
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Taoyuan, Taoyuan City, Taiwan, 33303
- Yi-Chien Chiang
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / 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.
|
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.
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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.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Sleep Quality at baseline
Time Frame: Data were collected before auricular acupressure intervention
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The Pittsburgh Sleep Quality Index (PSQI) is a validated multidimensional measure that assesses individuals' sleep quality.
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Data were collected before auricular acupressure intervention
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Sleep Quality at week 1
Time Frame: Data were collected in the first week after completing 5 days of auricular acupressure.
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The Pittsburgh Sleep Quality Index (PSQI) is a validated multidimensional measure that assesses individuals' sleep quality.
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Data were collected in the first week after completing 5 days of auricular acupressure.
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Sleep Quality at week 2
Time Frame: Data were collected in the second week after auricular acupressure interventtion.
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The Pittsburgh Sleep Quality Index (PSQI) is a validated multidimensional measure that assesses individuals' sleep quality.
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Data were collected in the second week after auricular acupressure interventtion.
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Sleep Quality at week 3
Time Frame: Data were collected in the 3rd week after auricular acupressure interventtion.
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The Pittsburgh Sleep Quality Index (PSQI) is a validated multidimensional measure that assesses individuals' sleep quality.
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Data were collected in the 3rd week after auricular acupressure interventtion.
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Mood State at baseline
Time Frame: Data were collected before auricular acupressure intervention
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The Profile of Mood State (POMS) was developed to investigate individuals' mood status.
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Data were collected before auricular acupressure intervention
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Mood State at week 1
Time Frame: Data were collected in the first week after completing 5 days of auricular acupressure.
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The Profile of Mood State (POMS) was developed to investigate individuals' mood status.
|
Data were collected in the first week after completing 5 days of auricular acupressure.
|
Mood State at week 2
Time Frame: Data were collected in the second week after auricular acupressure interventtion.
|
The Profile of Mood State (POMS) was developed to investigate individuals' mood status.
|
Data were collected in the second week after auricular acupressure interventtion.
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Mood State at week 3
Time Frame: Data were collected in the 3rd week after auricular acupressure interventtion.
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The Profile of Mood State (POMS) was developed to investigate individuals' mood status.
|
Data were collected in the 3rd week after auricular acupressure interventtion.
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Quality of Life Short-Form at baseline
Time Frame: Data were collected before auricular acupressure intervention
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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.
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Data were collected before auricular acupressure intervention
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Quality of Life Short-Form at week 1
Time Frame: 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.
|
Data were collected in the first week after completing 5 days of auricular acupressure.
|
Quality of Life Short-Form at week 2
Time Frame: 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.
|
Data were collected in the second week after auricular acupressure interventtion.
|
Quality of Life Short-Form at week 3
Time Frame: 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.
|
Data were collected in the 3rd week after auricular acupressure interventtion.
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Yi-Chien Chiang, PhD, Chang Gung University of Science and Technology
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- CMRPF1H0081
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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