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临床试验/NCT05052138
NCT05052138已完成不适用

Effects of Tactile Massage in Improving Older Residents' Psychological Health and Related Indicators in Long-Term Care Facilities

Taipei Medical University2 个研究点 分布在 1 个国家目标入组 73 人开始时间: 2022年8月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
73
试验地点
2
主要终点
University of California Los Angeles (UCLA)loneliness Scale version 3

研究概览

简要总结

The older residents in the long-term care facilities frequently experience loneliness, anxiety, and depressive symptoms. Improving residents' psychological health problems is one of the important tasks for nursing staff. Individual experiences a sense of security and feels of being cared for after tactile massage (TM).The randomized controlled trial research design and convenience sampling will be employed. Through skin-to-skin contact, the oxytocin can be induced to make individual feel relaxed, reduce anxiety, and feel pleasure. The randomized controlled trial research design and convenience sampling will be employed. The eligible residents will be randomly assigned to intervention group and comparison group (usual care). The intervention group will receive two 15-min tactile massages per week for 4 weeks. The comparison group will receive regular care and activities.

详细描述

The older residents in the long-term care facilities frequently experience loneliness, anxiety, and depressive symptoms. The negative emotions might affect residents' quality of life and even increase their mortality. Improving residents' psychological health problems is one of the important tasks for nursing staff. Individual experiences a sense of security and feels of being cared for after tactile massage (TM). Through skin-to-skin contact, the oxytocin can be induced to make individual feel relaxed, reduce anxiety, and feel pleasure. Moreover, TM does not need any tools and can be conducted at any time and any place. It is very convenient and accessible. Therefore, the purpose of this study is going to examine the effects of tactile massage in improving older residents' mental health and physiological effect in LTCFs. The randomized controlled trial research design and convenience sampling will be employed. LTCFs will be selected and contacted by researchers. The eligible residents will be randomly assigned to intervention group and comparison group (usual care). The intervention group will receive two 15-min tactile massages per week for 4 weeks. The comparison group will receive regular care and activities. Data will be collected at baseline, after intervention using questionnaires including demographic and related information questionnaire, University of California Los Angeles (UCLA) loneliness Scale version 3, Geriatric Anxiety Inventory, Geriatric Depression Scale short form (GDS-SF).Chinese Happiness Inventory, comfort Visual Analogue Scale, Relaxed Visual Analogue Scale, and vital signs. Data analysis will be conducted by performing percentage, mean, t-test, chi-square, and generalized estimating equations (GEE) using SPSS 22.0 software. Intention-to-treat analysis will be applied in this study.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Health Services Research
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
65 Years 至 —(Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •have lived in long-term care facilities for over one month
  • •conscious clear and can clearly express him or herself.

排除标准

  • •infection disease and skin problems
  • •psychiatric disorders
  • •loss sense of both hands.

研究组 & 干预措施

Tactile massage

Experimental

Tactile massage 1 will receivetwo 15-min tactile massages (hand massage) per week for 4 weeks

干预措施: Tactile massage (Other)

comparison group

No Intervention

The comparison group will receive regular care and activities.

结局指标

主要结局

University of California Los Angeles (UCLA)loneliness Scale version 3

时间窗: after the completion of the intervention(T1)

A 20-item scale designed to measure one's subjective feelings of loneliness as well as feelings of social isolation. Participants rate each item on a scale from 1 (Never) to 4 (Often). The total score ranged 20\~80 points, with a higher score indicating high level of loneliness

Geriatric Depression Scale short form (GDS-SF)

时间窗: after the completion of the intervention(T1)

The Geriatric Depression Scale is a 15-item "yes/no" self-report measure of depressive symptom.The individual is asked to report whether they have experienced these symptoms over the past week. The Geriatric Depression Scale has a maximum score of 15, with higher scores representing more severe symptoms.

heart rate(HR)

时间窗: after the completion of the intervention(T4)

measure heart rate, simply check pulse. To check your pulse at your wrist, two fingers between the bone and the tendon over your radial artery . ranges from 60 to 100 beats per minute.

breathing rate(RR)

时间窗: after the completion of the intervention(T4)

The respiration rate is the number of breaths a person takes per minute. The rate is usually measured when a person is at rest and simply involves counting the number of breaths for one minute by counting how many times the chest rises. The normal respiration rate for an adult at rest is 12 to 20 breaths per minute.

body temperature(BT)

时间窗: after the completion of the intervention(T4)

body temperature use ear thermometer measure temperature,normal body temperature can range between 36.1 C and 37.2 C .

Geriatric Anxiety Inventory (GAI)

时间窗: after the completion of the intervention(T1)

The Geriatric Anxiety Inventory is a 20-item "yes/no" self-report measure of Anxiety symptom.The individual is asked to report whether they have experienced these symptoms over the past week. The Geriatric Anxiety Inventory has a maximum score of 20, with higher scores representing more severe symptoms.

blood pressure(BP)

时间窗: after the completion of the intervention(T4)

Upper Arm blood pressure monitor measure, blood pressure is considered to be between 90/60 mmHg and 120/80 mmHg

University of California Los Angeles (UCLA)loneliness Scale version 3

时间窗: baseline, pre-intervention(T0)

A 20-item scale designed to measure one's subjective feelings of loneliness as well as feelings of social isolation. Participants rate each item on a scale from 1 (Never) to 4 (Often). The total score ranged 20\~80 points, with a higher score indicating high level of loneliness

Geriatric Depression Scale short form (GDS-SF)

时间窗: baseline, pre-intervention(T0)

The Geriatric Depression Scale is a 15-item "yes/no" self-report measure of depressive symptom.The individual is asked to report whether they have experienced these symptoms over the past week. The Geriatric Depression Scale has a maximum score of 15, with higher scores representing more severe symptoms.

Geriatric Anxiety Inventory (GAI)

时间窗: baseline, pre-intervention(T0)

The Geriatric Anxiety Inventory is a 20-item "yes/no" self-report measure of Anxiety symptom.The individual is asked to report whether they have experienced these symptoms over the past week. The Geriatric Anxiety Inventory has a maximum score of 20, with higher scores representing more severe symptoms.

body temperature(BT)

时间窗: baseline, pre-intervention(T0)

body temperature use ear thermometer measure temperature,normal body temperature can range between 36.1 C and 37.2 C .

body temperature(BT)

时间窗: through study completion, an average of 1 weeks(T1)

body temperature use ear thermometer measure temperature,normal body temperature can range between 36.1 C and 37.2 C .

body temperature(BT)

时间窗: through study completion,week 2 (T2)

body temperature use ear thermometer measure temperature,normal body temperature can range between 36.1 C and 37.2 C .

body temperature(BT)

时间窗: through study completion, week 3 (T3)

body temperature use ear thermometer measure temperature,normal body temperature can range between 36.1 C and 37.2 C .

blood pressure(BP)

时间窗: baseline, pre-intervention(T0)

Upper Arm blood pressure monitor measure, blood pressure is considered to be between 90/60 mmHg and 120/80 mmHg

blood pressure(BP)

时间窗: through study completion, an average of 1 weeks(T1)

Upper Arm blood pressure monitor measure, blood pressure is considered to be between 90/60 mmHg and 120/80 mmHg

blood pressure(BP)

时间窗: through study completion,week 2 (T2)

Upper Arm blood pressure monitor measure, blood pressure is considered to be between 90/60 mmHg and 120/80 mmHg

blood pressure(BP)

时间窗: through study completion, week 3 (T3)

Upper Arm blood pressure monitor measure, blood pressure is considered to be between 90/60 mmHg and 120/80 mmHg

heart rate(HR)

时间窗: baseline, pre-intervention(T0)

measure heart rate, simply check pulse. To check your pulse at your wrist, two fingers between the bone and the tendon over your radial artery . ranges from 60 to 100 beats per minute.

heart rate(HR)

时间窗: through study completion, an average of 1 weeks(T1)

measure heart rate, simply check pulse. To check your pulse at your wrist, two fingers between the bone and the tendon over your radial artery . ranges from 60 to 100 beats per minute.

heart rate(HR)

时间窗: through study completion,week 2 (T2)

measure heart rate, simply check pulse. To check your pulse at your wrist, two fingers between the bone and the tendon over your radial artery . ranges from 60 to 100 beats per minute.

heart rate(HR)

时间窗: through study completion, week 3 (T3)

measure heart rate, simply check pulse. To check your pulse at your wrist, two fingers between the bone and the tendon over your radial artery . ranges from 60 to 100 beats per minute.

breathing rate(RR)

时间窗: baseline, pre-intervention(T0)

The respiration rate is the number of breaths a person takes per minute. The rate is usually measured when a person is at rest and simply involves counting the number of breaths for one minute by counting how many times the chest rises. The normal respiration rate for an adult at rest is 12 to 20 breaths per minute.

breathing rate(RR)

时间窗: through study completion, an average of 1 weeks(T1)

The respiration rate is the number of breaths a person takes per minute. The rate is usually measured when a person is at rest and simply involves counting the number of breaths for one minute by counting how many times the chest rises. The normal respiration rate for an adult at rest is 12 to 20 breaths per minute.

breathing rate(RR)

时间窗: through study completion,week 2 (T2)

The respiration rate is the number of breaths a person takes per minute. The rate is usually measured when a person is at rest and simply involves counting the number of breaths for one minute by counting how many times the chest rises. The normal respiration rate for an adult at rest is 12 to 20 breaths per minute.

breathing rate(RR)

时间窗: through study completion, week 3 (T3)

The respiration rate is the number of breaths a person takes per minute. The rate is usually measured when a person is at rest and simply involves counting the number of breaths for one minute by counting how many times the chest rises. The normal respiration rate for an adult at rest is 12 to 20 breaths per minute.

次要结局

  • Chinese Happiness Inventory(after the completion of the intervention(T1))
  • Relaxed Visual Analogue Scale(after the completion of the intervention(T4))
  • comfort Visual Analogue Scale(after the completion of the intervention(T4))
  • Chinese Happiness Inventory(baseline, pre-intervention(T0))
  • comfort Visual Analogue Scale(baseline, pre-intervention(T0))
  • comfort Visual Analogue Scale(through study completion, an average of 1 weeks(T1))
  • comfort Visual Analogue Scale(through study completion, week 2 (T2))
  • comfort Visual Analogue Scale(through study completion, week 3 (T3))
  • Relaxed Visual Analogue Scale(baseline, pre-intervention(T0))
  • Relaxed Visual Analogue Scale(through study completion, an average of 1 weeks(T1))
  • Relaxed Visual Analogue Scale(through study completion, week 2 (T2))
  • Relaxed Visual Analogue Scale(through study completion, week 3 (T3))

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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