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

Status

Completed

Conditions

Intervention / Treatment

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

      • Taipei, Taiwan, 236
        • Tung Jen Hospital
    • Yilan
      • Tainan, Yilan, Taiwan, 27047
        • Suao Veterans Hospital

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.

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.

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.

Clinical Trials on Loneliness

Clinical Trials on Tactile massage

Subscribe