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

Parents of Children With Cancer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05654155
• Other study ID #: CMRPF1H0081
• Status: Completed
• Phase: N/A
• Start date: November 30, 2019
• Est. completion date: November 30, 2020

Study information

• Verified date: December 2022
• Source: Chang Gung University of Science and Technology
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 35
• Est. completion date: November 30, 2020
• Est. primary completion date: November 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Parents of Children With Cancer

Intervention

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.

Locations

Country	Name	City	State
Taiwan	Yi-Chien Chiang	Taoyuan	Taoyuan City

Sponsors (2)

Lead Sponsor	Collaborator
Chang Gung University of Science and Technology	Chang Gung Memorial Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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.
Primary	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.
Primary	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	Mood State at baseline	The Profile of Mood State (POMS) was developed to investigate individuals' mood status.	Data were collected before auricular acupressure intervention
Secondary	Mood State at week 1	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.
Secondary	Mood State at week 2	The Profile of Mood State (POMS) was developed to investigate individuals' mood status.	Data were collected in the second week after auricular acupressure interventtion.
Secondary	Mood State at week 3	The Profile of Mood State (POMS) was developed to investigate individuals' mood status.	Data were collected in the 3rd week after auricular acupressure interventtion.
Secondary	Quality of Life Short-Form at baseline	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 before auricular acupressure intervention
Secondary	Quality of Life Short-Form at week 1	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.
Secondary	Quality of Life Short-Form at week 2	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.
Secondary	Quality of Life Short-Form at week 3	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.