Clinical trial NCT05052138: Effects of Tactile Massage in Long-Term Care Facilities
Official title: Effects of Tactile Massage in Improving Older Residents' Psychological Health and Related Indicators in Long-Term Care Facilities
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Loneliness
Lead sponsor: Taipei Medical University
Sponsor class: OTHER
First posted: 2021-09-22
Enrollment: 73
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief 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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: University of California Los Angeles (UCLA)loneliness Scale version 3
timeFrame: baseline, pre-intervention(T0)
measure: University of California Los Angeles (UCLA)loneliness Scale version 3
timeFrame: after the completion of the intervention(T1)
measure: Geriatric Depression Scale short form (GDS-SF)
timeFrame: baseline, pre-intervention(T0)
measure: Geriatric Depression Scale short form (GDS-SF)
timeFrame: after the completion of the intervention(T1)
measure: Geriatric Anxiety Inventory (GAI)
timeFrame: baseline, pre-intervention(T0)
measure: Geriatric Anxiety Inventory (GAI)
timeFrame: after the completion of the intervention(T1)
measure: body temperature(BT)
timeFrame: baseline, pre-intervention(T0)
measure: body temperature(BT)
timeFrame: through study completion, an average of 1 weeks(T1)
measure: body temperature(BT)
timeFrame: through study completion,week 2 (T2)
measure: body temperature(BT)
timeFrame: through study completion, week 3 (T3)
measure: body temperature(BT)
timeFrame: after the completion of the intervention(T4)
measure: blood pressure(BP)
timeFrame: baseline, pre-intervention(T0)
measure: blood pressure(BP)
timeFrame: through study completion, an average of 1 weeks(T1)
measure: blood pressure(BP)
timeFrame: through study completion,week 2 (T2)
measure: blood pressure(BP)
timeFrame: through study completion, week 3 (T3)
measure: blood pressure(BP)
timeFrame: after the completion of the intervention(T4)
measure: heart rate(HR)
timeFrame: baseline, pre-intervention(T0)
measure: heart rate(HR)
timeFrame: through study completion, an average of 1 weeks(T1)
measure: heart rate(HR)
timeFrame: through study completion,week 2 (T2)
measure: heart rate(HR)
timeFrame: through study completion, week 3 (T3)
measure: heart rate(HR)
timeFrame: after the completion of the intervention(T4)
measure: breathing rate(RR)
timeFrame: baseline, pre-intervention(T0)
measure: breathing rate(RR)
timeFrame: through study completion, an average of 1 weeks(T1)
measure: breathing rate(RR)
timeFrame: through study completion,week 2 (T2)
measure: breathing rate(RR)
timeFrame: through study completion, week 3 (T3)
measure: breathing rate(RR)
timeFrame: after the completion of the intervention(T4)
Secondary outcomes:
measure: Chinese Happiness Inventory
timeFrame: baseline, pre-intervention(T0)
measure: Chinese Happiness Inventory
timeFrame: after the completion of the intervention(T1)
measure: comfort Visual Analogue Scale
timeFrame: baseline, pre-intervention(T0)
measure: comfort Visual Analogue Scale
timeFrame: through study completion, an average of 1 weeks(T1)
measure: comfort Visual Analogue Scale
timeFrame: through study completion, week 2 (T2)
measure: comfort Visual Analogue Scale
timeFrame: through study completion, week 3 (T3)
measure: comfort Visual Analogue Scale
timeFrame: after the completion of the intervention(T4)
measure: Relaxed Visual Analogue Scale
timeFrame: baseline, pre-intervention(T0)
measure: Relaxed Visual Analogue Scale
timeFrame: through study completion, an average of 1 weeks(T1)
measure: Relaxed Visual Analogue Scale
timeFrame: through study completion, week 2 (T2)
measure: Relaxed Visual Analogue Scale
timeFrame: through study completion, week 3 (T3)
measure: Relaxed Visual Analogue Scale
timeFrame: after the completion of the intervention(T4)
Other outcomes:
Locations:
city: Tainan
country: Taiwan
facility: Suao Veterans Hospital
state: Yilan
city: Taipei
country: Taiwan
facility: Tung Jen Hospital
Study officials:
affiliation: Taipei Medical University
name: Pi-Hua Huang
role: PRINCIPAL_INVESTIGATOR
References:
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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.
citation: 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.
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.
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 Demen. 2010 Dec;25(8):680-6. doi: 10.1177/1533317510386215.