Effects of Tactile Massage in Long-Term Care Facilities

NCT ID: NCT05052138

Last Updated: 2023-03-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 73 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-08-01
• Study Completion Date: 2022-12-25

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.

Conditions

Loneliness

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: SINGLE

Study Groups

Tactile massage

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

Group Type: EXPERIMENTAL

Tactile massage

Intervention Type: OTHER

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

comparison group

The comparison group will receive regular care and activities.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Tactile massage

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

Intervention Type: OTHER

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.

• Minimum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Taipei Medical University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Pi-Hua Huang

Role: PRINCIPAL_INVESTIGATOR

Taipei Medical University

Locations

Suao Veterans Hospital

Tainan City, Yilan, Taiwan

Tung Jen Hospital

Taipei, , Taiwan

Countries

Taiwan

References

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.

Reference Type: BACKGROUND

PMID: 30982141 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 30836612 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 22450009 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 26875503 (View on PubMed)

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.

Reference Type: RESULT

PMID: 21131675 (View on PubMed)

Huang PH, Chien WP, Lin YC, Chung MH, Lin PC, Lin YK, Chuang YH. Effects of Tactile Massage in Improving Older Residents' Psychological Health in Long-Term Care Facilities: A Randomised Controlled Trial. Int J Older People Nurs. 2024 Sep;19(5):e12652. doi: 10.1111/opn.12652.

Reference Type: DERIVED

PMID: 39312625 (View on PubMed)

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

N202002045

Identifier Type: -

Identifier Source: org_study_id