LonelinessNCT05052138
Effects of Tactile Massage in Long-Term Care Facilities
A study testing Tactile massage in people with Loneliness, run by Taipei Medical University at 2 sites in Taiwan.
Trial 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. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Loneliness
- What is being tested?
- Tactile massage
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 73 participants
- Where
- 2 sitesTaiwan
- Study dates
- 1 Aug 2022to 25 Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- have lived in long-term care facilities for over one month
- conscious clear and can clearly express him or herself.
Who cannot join
- infection disease and skin problems
- psychiatric disorders
- loss sense of both hands.
Trial locations and contacts
2 sites in 1 country.
Taiwan2 sites
Suao Veterans Hospital
Tainan, Yilan, 27047
Tung Jen Hospital
Taipei, 236
About this study
Official title: 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.
Read the 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
- Being tested
- Tactile massage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tactile massageOther
Tactile massage will receive two 15-min tactile massages(hand massage) per week for 4weeks
| Study group | Role | What they receive |
|---|---|---|
| Tactile massage | Experimental | Tactile massage 1 will receivetwo 15-min tactile massages (hand massage) per week for 4 weeks Receives: Other: Tactile massage |
| comparison group | No intervention | The comparison group will receive regular care and activities. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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 .
Measured: 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 .
Measured: 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 .
Measured: 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 .
Measured: 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 .
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: after the completion of the intervention(T4)
Secondary outcomes (12)
Chinese Happiness Inventory
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
Measured: baseline, pre-intervention(T0)
Chinese Happiness Inventory
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
Measured: after the completion of the intervention(T1)
comfort Visual Analogue Scale
providing a range of scores from 0-10. A higher score indicates greater comfort intensity
Measured: baseline, pre-intervention(T0)
comfort Visual Analogue Scale
providing a range of scores from 0-10. A higher score indicates greater comfort intensity
Measured: through study completion, an average of 1 weeks(T1)
comfort Visual Analogue Scale
providing a range of scores from 0-10. A higher score indicates greater comfort intensity
Measured: through study completion, week 2 (T2)
comfort Visual Analogue Scale
providing a range of scores from 0-10. A higher score indicates greater comfort intensity
Measured: through study completion, week 3 (T3)
comfort Visual Analogue Scale
providing a range of scores from 0-10. A higher score indicates greater comfort intensity
Measured: after the completion of the intervention(T4)
Relaxed Visual Analogue Scale
providing a range of scores from 0-10. A higher score indicates greater Relaxed intensity
Measured: baseline, pre-intervention(T0)
Relaxed Visual Analogue Scale
providing a range of scores from 0-10. A higher score indicates greater Relaxed intensity
Measured: through study completion, an average of 1 weeks(T1)
Relaxed Visual Analogue Scale
providing a range of scores from 0-10. A higher score indicates greater Relaxed intensity
Measured: through study completion, week 2 (T2)
Relaxed Visual Analogue Scale
providing a range of scores from 0-10. A higher score indicates greater Relaxed intensity
Measured: through study completion, week 3 (T3)
Relaxed Visual Analogue Scale
providing a range of scores from 0-10. A higher score indicates greater Relaxed intensity
Measured: after the completion of the intervention(T4)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2021
- Study start1 Aug 2022
- Primary completion13 Dec 2022
- Study completion25 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for LonelinessStudies of the same condition, open and under way.
- More trials run by Taipei Medical UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 73 participants (actual)
Sponsor and investigators
- Lead sponsor
- Taipei Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Pi-Hua Huang, Principal investigator, Taipei Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05052138
- Sponsor's protocol ID
- N202002045
- Status last verified
- Jul 2022
- First submitted
- 2 Sep 2021
- Last updated
- 27 Mar 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 30982141Nakano 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.
PubMed 30836612Kunikata 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.
PubMed 22450009McFeeters 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.
PubMed 26875503Suzuki 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.
PubMed 21131675Huang 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.
PubMed 39312625
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Tactile Massage in Improving Older Residents' Psychological Health and Related Indicators in Long-Term Care Facilities
- ClinicalTrials.gov ID
- NCT05052138
- Acronym / sponsor ID
- N202002045
- Conditions
- Loneliness
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 73 participants (actual)
- Lead sponsor
- Taipei Medical UniversityUniversity, hospital or other
- Study start
- 1 Aug 2022 (actual)
- Primary completion
- 13 Dec 2022 (actual)
- Study completion
- 25 Dec 2022 (actual)
- First posted
- 22 Sep 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tactile massage | Experimental | Other: Tactile massageTactile massage 1 will receivetwo 15-min tactile massages (hand massage) per week for 4 weeks |
| comparison group | No intervention | –The comparison group will receive regular care and activities. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (2 listed)
- have lived in long-term care facilities for over one month
- conscious clear and can clearly express him or herself.
Key exclusion criteria (3 listed)
- infection disease and skin problems
- psychiatric disorders
- loss sense of both hands.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tactile massageTactile massage will receive two 15-min tactile massages(hand massage) per week for 4weeks | Other | Tactile massage |
Primary outcome
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
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
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.
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.
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.
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.
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 .
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 .
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 .
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 .
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 .
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
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
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
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
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
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
12 secondary outcomes
Chinese Happiness Inventory
Time frame: baseline, pre-intervention(T0)
Chinese Happiness Inventory
Time frame: after the completion of the intervention(T1)
comfort Visual Analogue Scale
Time frame: baseline, pre-intervention(T0)
comfort Visual Analogue Scale
Time frame: through study completion, an average of 1 weeks(T1)
comfort Visual Analogue Scale
Time frame: through study completion, week 2 (T2)
comfort Visual Analogue Scale
Time frame: through study completion, week 3 (T3)
comfort Visual Analogue Scale
Time frame: after the completion of the intervention(T4)
Relaxed Visual Analogue Scale
Time frame: baseline, pre-intervention(T0)
Relaxed Visual Analogue Scale
Time frame: through study completion, an average of 1 weeks(T1)
Relaxed Visual Analogue Scale
Time frame: through study completion, week 2 (T2)
Relaxed Visual Analogue Scale
Time frame: through study completion, week 3 (T3)
Relaxed Visual Analogue Scale
Time frame: after the completion of the intervention(T4)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2023.
- Background: PubMed 30982141Yucel 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.
- Background: PubMed 30836612Nakano 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.
- Background: PubMed 22450009Kunikata 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.
- Background: PubMed 26875503McFeeters 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.
- Results publication: PubMed 21131675Suzuki 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.
- Derived from this study: PubMed 39312625Huang 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pi-Hua Huang principal investigator
Taipei Medical University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tactile massage in people with Loneliness, run by Taipei Medical University at 2 sites in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
University of California Los Angeles (UCLA)loneliness Scale version 3 (time frame: baseline, pre-intervention(T0)). The study lists 26 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05052138, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Mar 2023.