Clinical trial NCT05654155: The Effectiveness of Auricular Acupressure on Sleep Quality, Mood Status, and Quality of Life
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Parents of Children With Cancer
Keywords: sleep quality
quality of life
auricular acupressure
Lead sponsor: Chang Gung University of Science and Technology
Sponsor class: OTHER
Collaborators: name: Chang Gung Memorial Hospital
First posted: 2022-12-16
Enrollment: 35
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Sleep Quality at baseline
timeFrame: Data were collected before auricular acupressure intervention
measure: Sleep Quality at week 1
timeFrame: Data were collected in the first week after completing 5 days of auricular acupressure.
measure: Sleep Quality at week 2
timeFrame: Data were collected in the second week after auricular acupressure interventtion.
measure: Sleep Quality at week 3
timeFrame: Data were collected in the 3rd week after auricular acupressure interventtion.
Secondary outcomes:
measure: Mood State at baseline
timeFrame: Data were collected before auricular acupressure intervention
measure: Mood State at week 1
timeFrame: Data were collected in the first week after completing 5 days of auricular acupressure.
measure: Mood State at week 2
timeFrame: Data were collected in the second week after auricular acupressure interventtion.
measure: Mood State at week 3
timeFrame: Data were collected in the 3rd week after auricular acupressure interventtion.
measure: Quality of Life Short-Form at baseline
timeFrame: Data were collected before auricular acupressure intervention
measure: Quality of Life Short-Form at week 1
timeFrame: Data were collected in the first week after completing 5 days of auricular acupressure.
measure: Quality of Life Short-Form at week 2
timeFrame: Data were collected in the second week after auricular acupressure interventtion.
measure: Quality of Life Short-Form at week 3
timeFrame: Data were collected in the 3rd week after auricular acupressure interventtion.
Other outcomes:
Locations:
city: Taoyuan
country: Taiwan
facility: Yi-Chien Chiang
state: Taoyuan City
Study officials:
affiliation: Chang Gung University of Science and Technology
name: Yi-Chien Chiang, PhD
role: PRINCIPAL_INVESTIGATOR
References: