Effects of Tactile Massage in Long-Term Care Facilities

Loneliness Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05052138
• Other study ID #: N202002045
• Status: Completed
• Phase: N/A
• Start date: August 1, 2022
• Est. completion date: December 25, 2022

Study information

• Verified date: July 2022
• Source: Taipei Medical University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 73
• Est. completion date: December 25, 2022
• Est. primary completion date: December 13, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Loneliness

Intervention

Other:
• Tactile massage
Tactile massage will receive two 15-min tactile massages(hand massage) per week for 4weeks

Locations

Country	Name	City	State
Taiwan	Suao Veterans Hospital	Tainan	Yilan
Taiwan	Tung Jen Hospital	Taipei

Sponsors (1)

Lead Sponsor	Collaborator
Taipei Medical University

Country where clinical trial is conducted

Taiwan, 

References & Publications (5)

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. — View Citation

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. — View Citation

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. — View Citation

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 — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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	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)
Secondary	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)
Secondary	comfort Visual Analogue Scale	providing a range of scores from 0-10. A higher score indicates greater comfort intensity	baseline, pre-intervention(T0)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	Relaxed Visual Analogue Scale	providing a range of scores from 0-10. A higher score indicates greater Relaxed intensity	baseline, pre-intervention(T0)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)