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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
73

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

  • Taiwan
      • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Tactile massage
Tactile massage 1 will receivetwo 15-min tactile massages (hand massage) per week for 4 weeks
Other: Tactile massage
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Taipei Medical University

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.

General Publications

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 1, 2022

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 13, 2022

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 25, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 2, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 10, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 22, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 27, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 23, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2022

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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.

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