NCT05052138

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
73

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Aug 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 2, 2021

Completed
20 days until next milestone

First Posted

Study publicly available on registry

September 22, 2021

Completed
10 months until next milestone

Study Start

First participant enrolled

August 1, 2022

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 13, 2022

Completed
12 days until next milestone

Study Completion

Last participant's last visit for all outcomes

December 25, 2022

Completed
Last Updated

March 27, 2023

Status Verified

July 1, 2022

Enrollment Period

4 months

First QC Date

September 2, 2021

Last Update Submit

March 23, 2023

Conditions

Outcome Measures

Primary Outcomes (26)

  • 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 Outcomes (12)

  • Chinese Happiness Inventory

    baseline, pre-intervention(T0)

  • Chinese Happiness Inventory

    after the completion of the intervention(T1)

  • comfort Visual Analogue Scale

    baseline, pre-intervention(T0)

  • comfort Visual Analogue Scale

    through study completion, an average of 1 weeks(T1)

  • comfort Visual Analogue Scale

    through study completion, week 2 (T2)

  • +7 more secondary outcomes

Study Arms (2)

Tactile massage

EXPERIMENTAL

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

Other: Tactile massage

comparison group

NO INTERVENTION

The comparison group will receive regular care and activities.

Interventions

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

Tactile massage

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • have lived in long-term care facilities for over one month
  • conscious clear and can clearly express him or herself.

You may not qualify if:

  • infection disease and skin problems
  • psychiatric disorders
  • loss sense of both hands.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Suao Veterans Hospital

Tainan, Yilan, 27047, Taiwan

Location

Tung Jen Hospital

Taipei, 236, Taiwan

Location

Related Publications (6)

  • 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.

    PMID: 30982141BACKGROUND
  • 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.

    PMID: 30836612BACKGROUND
  • 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.

    PMID: 22450009BACKGROUND
  • 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.

    PMID: 26875503BACKGROUND
  • 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.

  • 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.

Study Officials

  • Pi-Hua Huang

    Taipei Medical University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 2, 2021

First Posted

September 22, 2021

Study Start

August 1, 2022

Primary Completion

December 13, 2022

Study Completion

December 25, 2022

Last Updated

March 27, 2023

Record last verified: 2022-07

Data Sharing

IPD Sharing
Will not share

Locations