Effects of Tactile Massage in Long-Term Care Facilities

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Loneliness

Intervention / Treatment
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* Other: Tactile massage


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: have lived in long-term care facilities for over one month conscious clear and can clearly express him or herself. Exclusion Criteria: infection disease and skin problems psychiatric disorders loss sense of both hands.

Ages Eligible for Study
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Minimum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Tactile massage<br>Tactile massage 1 will receivetwo 15-min tactile massages (hand massage) per week for 4 weeks | Other: Tactile massage<br>* Tactile massage will receive two 15-min tactile massages(hand massage) per week for 4weeks<br>|
| No Intervention: comparison group<br>The comparison group will receive regular care and activities. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| University of California Los Angeles (UCLA)loneliness Scale version 3 | 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 | baseline, pre-intervention(T0) | 
| University of California Los Angeles (UCLA)loneliness Scale version 3 | 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 | after the completion of the intervention(T1) | 
| Geriatric Depression Scale short form (GDS-SF) | 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. | baseline, pre-intervention(T0) | 
| Geriatric Depression Scale short form (GDS-SF) | 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. | after the completion of the intervention(T1) | 
| Geriatric Anxiety Inventory (GAI) | 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. | baseline, pre-intervention(T0) | 
| Geriatric Anxiety Inventory (GAI) | 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. | after the completion of the intervention(T1) | 
| body temperature(BT) | body temperature use ear thermometer measure temperature，normal body temperature can range between 36.1 C and 37.2 C . | baseline, pre-intervention(T0) | 
| body temperature(BT) | body temperature use ear thermometer measure temperature，normal body temperature can range between 36.1 C and 37.2 C . | through study completion, an average of 1 weeks(T1) | 
| body temperature(BT) | body temperature use ear thermometer measure temperature，normal body temperature can range between 36.1 C and 37.2 C . | through study completion,week 2 (T2) | 
| body temperature(BT) | body temperature use ear thermometer measure temperature，normal body temperature can range between 36.1 C and 37.2 C . | through study completion, week 3 (T3) | 
| body temperature(BT) | body temperature use ear thermometer measure temperature，normal body temperature can range between 36.1 C and 37.2 C . | after the completion of the intervention(T4) | 
| blood pressure(BP) | Upper Arm blood pressure monitor measure, blood pressure is considered to be between 90/60 mmHg and 120/80 mmHg | baseline, pre-intervention(T0) | 
| blood pressure(BP) | Upper Arm blood pressure monitor measure, blood pressure is considered to be between 90/60 mmHg and 120/80 mmHg | through study completion, an average of 1 weeks(T1) | 
| blood pressure(BP) | Upper Arm blood pressure monitor measure, blood pressure is considered to be between 90/60 mmHg and 120/80 mmHg | through study completion,week 2 (T2) | 
| blood pressure(BP) | Upper Arm blood pressure monitor measure, blood pressure is considered to be between 90/60 mmHg and 120/80 mmHg | through study completion, week 3 (T3) | 
| blood pressure(BP) | Upper Arm blood pressure monitor measure, blood pressure is considered to be between 90/60 mmHg and 120/80 mmHg | after the completion of the intervention(T4) | 
| heart rate(HR) | 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. | baseline, pre-intervention(T0) | 
| heart rate(HR) | 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. | through study completion, an average of 1 weeks(T1) | 
| heart rate(HR) | 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. | through study completion,week 2 (T2) | 
| heart rate(HR) | 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. | through study completion, week 3 (T3) | 
| heart rate(HR) | 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. | after the completion of the intervention(T4) | 
| breathing rate(RR) | 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. | baseline, pre-intervention(T0) | 
| breathing rate(RR) | 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. | through study completion, an average of 1 weeks(T1) | 
| breathing rate(RR) | 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. | through study completion,week 2 (T2) | 
| breathing rate(RR) | 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. | through study completion, week 3 (T3) | 
| breathing rate(RR) | 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. | after the completion of the intervention(T4) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Chinese Happiness Inventory | A 10-item scale designed to measure one's subjective feelings of Happiness . Participants rate each item on a scale from 0 to 3. The total score ranged 0 30 points, with a higher score indicating high level of happy | baseline, pre-intervention(T0) | 
| Chinese Happiness Inventory | A 10-item scale designed to measure one's subjective feelings of Happiness . Participants rate each item on a scale from 0 to 3. The total score ranged 0 30 points, with a higher score indicating high level of happy | after the completion of the intervention(T1) | 
| comfort Visual Analogue Scale | providing a range of scores from 0-10. A higher score indicates greater comfort intensity | baseline, pre-intervention(T0) | 
| comfort Visual Analogue Scale | providing a range of scores from 0-10. A higher score indicates greater comfort intensity | through study completion, an average of 1 weeks(T1) | 
| comfort Visual Analogue Scale | providing a range of scores from 0-10. A higher score indicates greater comfort intensity | through study completion, week 2 (T2) | 
| comfort Visual Analogue Scale | providing a range of scores from 0-10. A higher score indicates greater comfort intensity | through study completion, week 3 (T3) | 
| comfort Visual Analogue Scale | providing a range of scores from 0-10. A higher score indicates greater comfort intensity | after the completion of the intervention(T4) | 
| Relaxed Visual Analogue Scale | providing a range of scores from 0-10. A higher score indicates greater Relaxed intensity | baseline, pre-intervention(T0) | 
| Relaxed Visual Analogue Scale | providing a range of scores from 0-10. A higher score indicates greater Relaxed intensity | through study completion, an average of 1 weeks(T1) | 
| Relaxed Visual Analogue Scale | providing a range of scores from 0-10. A higher score indicates greater Relaxed intensity | through study completion, week 2 (T2) | 
| Relaxed Visual Analogue Scale | providing a range of scores from 0-10. A higher score indicates greater Relaxed intensity | through study completion, week 3 (T3) | 
| Relaxed Visual Analogue Scale | providing a range of scores from 0-10. A higher score indicates greater Relaxed intensity | after the completion of the intervention(T4) |