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临床试验/NCT05654155
NCT05654155已完成不适用

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

Chang Gung University of Science and Technology2 个研究点 分布在 1 个国家目标入组 35 人开始时间: 2019年11月30日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
35
试验地点
2
主要终点
Sleep Quality at baseline

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Participant)

入排标准

性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 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.

结局指标

主要结局

Sleep Quality at baseline

时间窗: Data were collected before auricular acupressure intervention

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

Sleep Quality at week 3

时间窗: 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.

Sleep Quality at week 1

时间窗: 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.

Sleep Quality at week 2

时间窗: 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.

次要结局

  • Mood State at week 1(Data were collected in the first week after completing 5 days of auricular acupressure.)
  • Mood State at baseline(Data were collected before auricular acupressure intervention)
  • Mood State at week 2(Data were collected in the second week after auricular acupressure interventtion.)
  • Mood State at week 3(Data were collected in the 3rd week after auricular acupressure interventtion.)
  • Quality of Life Short-Form at week 1(Data were collected in the first week after completing 5 days of auricular acupressure.)
  • Quality of Life Short-Form at week 2(Data were collected in the second week after auricular acupressure interventtion.)
  • Quality of Life Short-Form at baseline(Data were collected before auricular acupressure intervention)
  • Quality of Life Short-Form at week 3(Data were collected in the 3rd week after auricular acupressure interventtion.)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Yi-Chien Chiang

Associate professor

Chang Gung University of Science and Technology

研究点 (2)

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