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Completed

NCT Number: NCT05052138

Effects of Tactile Massage 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.

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Key information

Conditions

Loneliness

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Suao Veterans Hospital, Tainan, Yilan, Taiwan

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Tactile massage

Other

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

Primary outcomes

  1. 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

  2. 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

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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 .

  8. 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 .

  9. 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 .

  10. 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 .

  11. 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 .

  12. 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

  13. 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

  14. 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

  15. 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

  16. 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

  17. 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.

  18. 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.

  19. 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.

  20. 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.

  21. 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.

  22. 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.

  23. 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.

  24. 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.

  25. 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.

  26. 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.

Secondary outcomes

  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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

  7. 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

  8. 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

  9. 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

  10. 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

  11. 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

  12. 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

Sponsors and collaborators

Lead sponsor

Taipei Medical University

Other

Registry information

Official study title

Effects of Tactile Massage in Improving Older Residents' Psychological Health and Related Indicators in Long-Term Care Facilities

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Sep 22, 2021
Registry last updated
Mar 27, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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