- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05052138
Effects of Tactile Massage in Long-Term Care Facilities
March 23, 2023 updated by: Taipei Medical University
Effects of Tactile Massage in Improving Older Residents' Psychological Health and Related Indicators in Long-Term Care Facilities
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.
Study Overview
Detailed Description
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.
Study Type
Interventional
Enrollment (Actual)
73
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Taipei, Taiwan, 236
- Tung Jen Hospital
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Yilan
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Tainan, Yilan, Taiwan, 27047
- Suao Veterans Hospital
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
65 years and older (Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Tactile massage
Tactile massage 1 will receivetwo 15-min tactile massages (hand massage) per week for 4 weeks
|
Tactile massage will receive two 15-min tactile massages(hand massage) per week for 4weeks
|
|
No Intervention: comparison group
The comparison group will receive regular care and activities.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
University of California Los Angeles (UCLA)loneliness Scale version 3
Time Frame: 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
|
baseline, pre-intervention(T0)
|
|
University of California Los Angeles (UCLA)loneliness Scale version 3
Time Frame: 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
|
after the completion of the intervention(T1)
|
|
Geriatric Depression Scale short form (GDS-SF)
Time Frame: 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.
|
baseline, pre-intervention(T0)
|
|
Geriatric Depression Scale short form (GDS-SF)
Time Frame: 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.
|
after the completion of the intervention(T1)
|
|
Geriatric Anxiety Inventory (GAI)
Time Frame: 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.
|
baseline, pre-intervention(T0)
|
|
Geriatric Anxiety Inventory (GAI)
Time Frame: 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.
|
after the completion of the intervention(T1)
|
|
body temperature(BT)
Time Frame: baseline, pre-intervention(T0)
|
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)
Time Frame: 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 .
|
through study completion, an average of 1 weeks(T1)
|
|
body temperature(BT)
Time Frame: 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 .
|
through study completion,week 2 (T2)
|
|
body temperature(BT)
Time Frame: 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 .
|
through study completion, week 3 (T3)
|
|
body temperature(BT)
Time Frame: 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 .
|
after the completion of the intervention(T4)
|
|
blood pressure(BP)
Time Frame: baseline, pre-intervention(T0)
|
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)
Time Frame: 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
|
through study completion, an average of 1 weeks(T1)
|
|
blood pressure(BP)
Time Frame: 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
|
through study completion,week 2 (T2)
|
|
blood pressure(BP)
Time Frame: 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
|
through study completion, week 3 (T3)
|
|
blood pressure(BP)
Time Frame: 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
|
after the completion of the intervention(T4)
|
|
heart rate(HR)
Time Frame: 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.
|
baseline, pre-intervention(T0)
|
|
heart rate(HR)
Time Frame: 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.
|
through study completion, an average of 1 weeks(T1)
|
|
heart rate(HR)
Time Frame: 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.
|
through study completion,week 2 (T2)
|
|
heart rate(HR)
Time Frame: 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.
|
through study completion, week 3 (T3)
|
|
heart rate(HR)
Time Frame: 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.
|
after the completion of the intervention(T4)
|
|
breathing rate(RR)
Time Frame: 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.
|
baseline, pre-intervention(T0)
|
|
breathing rate(RR)
Time Frame: 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.
|
through study completion, an average of 1 weeks(T1)
|
|
breathing rate(RR)
Time Frame: 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.
|
through study completion,week 2 (T2)
|
|
breathing rate(RR)
Time Frame: 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.
|
through study completion, week 3 (T3)
|
|
breathing rate(RR)
Time Frame: 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.
|
after the completion of the intervention(T4)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Chinese Happiness Inventory
Time Frame: baseline, pre-intervention(T0)
|
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
Time Frame: after the completion of the intervention(T1)
|
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
Time Frame: baseline, pre-intervention(T0)
|
providing a range of scores from 0-10.
A higher score indicates greater comfort intensity
|
baseline, pre-intervention(T0)
|
|
comfort Visual Analogue Scale
Time Frame: through study completion, an average of 1 weeks(T1)
|
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
Time Frame: through study completion, week 2 (T2)
|
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
Time Frame: through study completion, week 3 (T3)
|
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
Time Frame: after the completion of the intervention(T4)
|
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
Time Frame: baseline, pre-intervention(T0)
|
providing a range of scores from 0-10.
A higher score indicates greater Relaxed intensity
|
baseline, pre-intervention(T0)
|
|
Relaxed Visual Analogue Scale
Time Frame: through study completion, an average of 1 weeks(T1)
|
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
Time Frame: through study completion, week 2 (T2)
|
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
Time Frame: through study completion, week 3 (T3)
|
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
Time Frame: after the completion of the intervention(T4)
|
providing a range of scores from 0-10.
A higher score indicates greater Relaxed intensity
|
after the completion of the intervention(T4)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Yucel SC, Arslan GG, Bagci H. Effects of Hand Massage and Therapeutic Touch on Comfort and Anxiety Living in a Nursing Home in Turkey: A Randomized Controlled Trial. J Relig Health. 2020 Feb;59(1):351-364. doi: 10.1007/s10943-019-00813-x.
- Nakano H, Kodama T, Ueda T, Mori I, Tani T, Murata S. Effect of Hand and Foot Massage Therapy on Psychological Factors and EEG Activity in Elderly People Requiring Long-Term Care: A Randomized Cross-Over Study. Brain Sci. 2019 Mar 4;9(3):54. doi: 10.3390/brainsci9030054.
- Kunikata H, Watanabe K, Miyoshi M, Tanioka T. The effects measurement of hand massage by the autonomic activity and psychological indicators. J Med Invest. 2012;59(1-2):206-12. doi: 10.2152/jmi.59.206.
- McFeeters S, Pront L, Cuthbertson L, King L. Massage, a complementary therapy effectively promoting the health and well-being of older people in residential care settings: a review of the literature. Int J Older People Nurs. 2016 Dec;11(4):266-283. doi: 10.1111/opn.12115. Epub 2016 Feb 15.
- Suzuki M, Tatsumi A, Otsuka T, Kikuchi K, Mizuta A, Makino K, Kimoto A, Fujiwara K, Abe T, Nakagomi T, Hayashi T, Saruhara T. Physical and psychological effects of 6-week tactile massage on elderly patients with severe dementia. Am J Alzheimers Dis Other Demen. 2010 Dec;25(8):680-6. doi: 10.1177/1533317510386215.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
August 1, 2022
Primary Completion (Actual)
December 13, 2022
Study Completion (Actual)
December 25, 2022
Study Registration Dates
First Submitted
September 2, 2021
First Submitted That Met QC Criteria
September 10, 2021
First Posted (Actual)
September 22, 2021
Study Record Updates
Last Update Posted (Actual)
March 27, 2023
Last Update Submitted That Met QC Criteria
March 23, 2023
Last Verified
July 1, 2022
More Information
Terms related to this study
Other Study ID Numbers
- N202002045
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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