Hand MassageNCT06360614
The Effect of Hand Massage Applied to Palliative Care Oncology Patients
A study testing Hand massage application and routine monitoring and nursing care in people with Hand Massage, run by murat koç at 1 site in Turkey (Türkiye).
Trial summary
World Health Organization (WHO) palliative care is defined as "an approach that aims to reduce or prevent suffering by early identification, evaluation and treatment of the physical, psychosocial and spiritual problems of patients and families accompanying life-threatening diseases, and thus to increase their quality… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hand Massage
- What is being tested?
- Hand massage application and routine monitoring and nursing care
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 76 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 May 2024to 19 Jul 2025
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Oncology patients receiving treatment for at least 2 weeks in palliative care.
- 18 years and over.
- Able to communicate clearly and effectively.
- Visual Analogue Scale-Pain score above 3.
- Pittsburgh Sleep Quality Index score above 5.
- Without a neurological medical diagnosis.
- There is no intravenous catheter on the hand and there is no deformity in the hand.
Who cannot join
- Less than 2 weeks of treatment in palliative care.
- Under 18 years of age.
- Outside the clinical protocol use analgesic medication or methods.
- A change in the standard protocol for pain and sleep.
- Visual Analogue Scale-Pain score below 3.
- Pittsburgh Sleep Quality Index score below 5.
- Unable to communicate effectively.
- Patients with diagnosed neurological problems and hand deformities.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Sultanbeyli State Hospital
Istanbul, Istanbul, 34000
About this study
Official title: The Effect of Hand Massage Applied to Palliative Care Oncology Patients on Pain, Comfort and Sleep Quality
World Health Organization (WHO) palliative care is defined as "an approach that aims to reduce or prevent suffering by early identification, evaluation and treatment of the physical, psychosocial and spiritual problems of patients and families accompanying life-threatening diseases, and thus to increase their quality of life." Palliative care is a multidisciplinary approach that provides appropriate health care for oncology patients, who have a wide variety of medical, functional, social and emotional needs. Pharmacological approaches are generally used in symptom management of palliative care patients. In addition to pharmacological approaches, non-pharmacological approaches are also preferred. Massage is a preferred intervention among professional nursing practices because it is reliable, has no side effects, has a direct effect on patients, and is easy to apply.
Massage is the stimulation of the skin, subcutaneous tissue, muscles, internal organs, metabolism, circulation and lymph systems for therapeutic purposes through mechanical and neural means. The presence of sufficient mechanoreceptors in the hands, which stimulate painless nerve endings, shows that the hands should be chosen as the appropriate area for massage. Among the effects of hand massage: ensuring the regeneration of cells, facilitating the elimination of accumulated toxins, providing relaxation, helping to reduce pain by facilitating the release of endorphins, helping to increase circulation, regulating respiratory functions, providing stress and anxiety control, creating a state of well-being, strengthening the immune system, increasing general comfort, improving sleep quality. is located. Studies in the literature have found that hand massage reduces anxiety levels, stress and agitation levels, pain levels, and increases comfort and sleep levels. As seen in the literature, the effectiveness of hand massage applied to different sample groups on anxiety, stress, agitation, pain, comfort and sleep parameters was evaluated. There are very few studies evaluating the effectiveness of hand massage applied to oncology patients. In addition, no study has been found that evaluated the effects of hand massage on pain, comfort and sleep in palliative oncology patients, who constitute the majority of palliative care patients.
Read the detailed description
There is a rapid increase in cancer incidence and mortality worldwide. The International Agency for Research on Cancer (IARC) 2018 found that 18.1 million individuals were diagnosed with cancer worldwide. Individuals diagnosed with cancer experience many symptoms during the disease process, during the treatment phase, and in the terminal period. In most patients, many symptoms such as pain, insomnia, nausea and vomiting, anorexia, shortness of breath and fatigue are frequently observed, depending on the type and stage of cancer, treatments applied and accompanying diseases. Failure to control these symptoms affects the treatment process and may cause patients and family members to experience difficulties in the fight against cancer. During this period, the most effective way to meet all the needs of the patient and his family is to receive palliative care services. Palliative care is the key to individualized and holistic care. The scope of palliative care includes defining goals of care based on the patient's values and beliefs and addressing patients' physical, emotional, spiritual, and social problems. Palliative care is a multidisciplinary approach in which appropriate health care is provided for oncology patients, who have a wide range of medical, functional, social and emotional needs. Pharmacological approaches are generally used in symptom management of palliative care patients. In addition to pharmacological approaches, non-pharmacological approaches are also preferred. Practices such as reflexology, music therapy, acupuncture, aromatherapy, pet therapy, therapeutic touch, reiki, massage, hand massage therapy are non-pharmacological applications that can be used in palliative care oncology patients.
Massage is a preferred intervention among professional nursing practices because it is reliable, has no side effects, has a direct effect on patients, and is easy to apply. Massage is the stimulation of the skin, subcutaneous tissue, muscles, internal organs, metabolism, circulation and lymph systems for therapeutic purposes through mechanical and neural means . The presence of sufficient mechanoreceptors in the hands, which stimulate painless nerve endings, shows that the hands should be chosen as the appropriate area for massage. Hand massage application changes the sensation of pain in the neuromatrix. It increases the stimulation of large nerve fibers on the small C nerve fiber in the spinothalamic system through the spinal cord and reduces the sensation and transmission of pain by increasing blood flow to the hands. With the application of hand massage, sensory information is transferred from the hands to the spinothalamic pathway via the thalamus and somatosensory cortex via the spinal cord. While sensory information changes within the neuromatrix structure, it also reduces chronic pain. The scope of hand massage is limited, but it is a more accessible area. In addition, it can be applied more easily and conveniently than whole body massage due to its pain-reducing and comfort-increasing effect Among the effects of hand massage: ensuring the regeneration of cells, facilitating the elimination of accumulated toxins, providing relaxation, helping to reduce pain by facilitating the release of endorphins, helping to increase circulation, regulating respiratory functions, providing stress and anxiety control, creating a state of well-being, strengthening the immune system, increasing general comfort, improving sleep quality. Studies in the literature show that hand massage reduces anxiety levels, pain levels, stress and agitation levels; It has been stated that it is effective in increasing the level of comfort and sleep quality.
As seen in the literature, the effectiveness of hand massage applied to different sample groups on anxiety, stress, agitation, pain, comfort and sleep parameters was evaluated. There are very few studies evaluating the effectiveness of hand massage applied to oncology patients. In addition, no study has been found that evaluated the effects of hand massage on pain, comfort and sleep in palliative oncology patients, who constitute the majority of palliative care patients. Hand massage, which is a practical, safe and cost-free method in symptom management, which forms the basis of palliative care and has an important place in the treatment of oncology patients, should be used by evaluating its effectiveness.
- Conditions
- Hand Massage
- Being tested
- Hand massage application, routine monitoring and nursing care
- Keywords
- Palliative care, Oncology, Hand massage, Pain, Comfort, Sleep quality
- Medical subject headings
- Neoplasms, Pain, Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hand massage applicationOther
2 sessions of hand massage every day, 2 days a week (Monday and Friday) for 4 weeks
routine monitoring and nursing careOther
Routine monitoring and nursing care for 4 weeks
| Study group | Role | What they receive |
|---|---|---|
| Hand massage application | Experimental | Hand massage will be applied to the intervention group for 4 weeks, 2 days a week (Monday and Friday), 2 sessions each day. Receives: Other: Hand massage application |
| Control Group | Placebo comparator | The control group will receive routine monitoring and nursing care for 4 weeks. Receives: Other: routine monitoring and nursing care |
What is being measured
The primary outcome is the main question the study is designed to answer.
İndividual Information Form
Prepared by the researcher in accordance with the purpose of the research. The Personal Information Form consists of questions about individuals' socio-demographic characteristics, pain and sleep patterns.
Measured: 4 weeks
Patient Follow-up Form
It was prepared by the researcher in accordance with the purpose of the study. The Patient Monitoring Form allows recording of VAS-Pain, General Comfort Scale and Pittsburgh Sleep Quality Index scores evaluated on days 0, 7, 14 and 28.
Measured: 4 weeks
General Comfort Scale
It is used to determine the needs in providing comfort and to evaluate the results of nursing interventions aimed at comfort. The General Comfort Scale, which is suitable for Turkish society by Kuğuoğlu and Karabacak (2004), is a four- and six-point Likert type, contains 24 positive and 24 negative items, and the response patterns are mixed.
The highest total score to be obtained from the scale is 192, and the lowest total score is 48. The average value is determined by dividing the total score obtained by the number of scale items and the result is stated as 20 in the 1-4 distribution. Thus, the comfort level; Low comfort is expressed in a range of one point and high comfort is expressed in a range of four points. As a result of the Turkish validity-reliability study of GKS, it was found that the reliability of the scale was high (Cronbach's alpha = 0.85).
Measured: 4 weeks
Pittsburgh Sleep Quality Index
The validity and reliability study of the scale in our country (Cronbach Alpha = 0.80) was conducted by Ağargün et al. in 1996. PSQI, which evaluates sleep quality in the last month, contains a total of 24 questions. 19 of these are self-report questions and are answered by the patient, while 5 questions are answered by a spouse or a roommate and are used only for clinical information and are not included in scoring. The scale consists of seven components: Subjective Sleep Quality, Sleep Latency, Sleep Duration, Sleep Efficiency, Sleep Disorder, Sleeping Medication Use, and Daytime Dysfunction. In the scale scoring, Subjective Sleep Quality, Sleep Duration and Sleeping Medication Use components are scored between 0-3 depending on the answer given. The total score obtained varies between 0-21 points, and high scores indicate poor sleep quality and high level of sleep disturbance. A total score of 5 or more from the scale indicates that sleep quality is significantly poor.
Measured: 4 weeks
Smart Bracelet
Recording sleep/wake data of patients receiving hand massage; Smart bracelets were used to monitor sleep quality and process. The smart bracelet tracks your sleep patterns and provides information such as the time you fell asleep, the time you woke up, how many times you woke up during the night, and how long it took you to fall asleep each time. The sleep time measured by the smart bracelet is accessed through applications installed on smartphones by the researcher. Xiaomi Smart band 8 Pro was used to measure sleep times. The calibration of the device was carried out monthly at Xiaomi authorized service.
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2024
- Study start15 May 2024
- Primary completion20 Jun 2025
- Study completion19 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for Hand MassageStudies of the same condition, open and under way.
- 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
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Before the application, data will be collected and recorded through a face-to-face interview (8-10 minutes) by a nurse who does not know which group the patients are in. Sleep times of patients will be measured with a smart bracelet. At this stage, the same procedure will be continued for the intervention and control groups. Hand massage will be applied to the intervention group for 4 weeks, 2 days a week (Monday and Friday), 2 sessions each day. The control group will receive routine monitoring and nursing care for 4 weeks. In the intervention and control groups, VAS-Pain, General Comfort Scale and Pittsburgh Sleep Quality were assessed by a face-to-face interview by a nurse who did not know which group the patients were in, on the 7th day (Monday), 14th day (Monday) and 28th day (Monday). Index measurement tools will be applied and patients' sleep times will be measured with a smart bracelet.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 76 participants (actual)
Sponsor and investigators
- Lead sponsor
- murat koç
- Sponsor type
- Other government
- Collaborators
- Istanbul Sultanbeyli State Hospital
- Responsible party
- Sponsor-investigator, murat koç, Istanbul Sultanbeyli State Hospital
- Investigators
- Murat Koç, Principal investigator, Istanbul Sultanbeyli State HospitalNurdan Yalçın ATAR, Principal investigator, Saglik Bilimleri Universitesi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06360614
- Sponsor's protocol ID
- 2024s01
- Status last verified
- Jul 2025
- First submitted
- 7 Apr 2024
- Last updated
- 23 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Harris D. Safe and effective prescribing for symptom management in palliative care. Br J Hosp Med (Lond). 2019 Dec 2;80(12):C184-C189. doi: 10.12968/hmed.2019.80.12.C184.
PubMed 31822173Hokka M, Kaakinen P, Polkki T. A systematic review: non-pharmacological interventions in treating pain in patients with advanced cancer. J Adv Nurs. 2014 Sep;70(9):1954-1969. doi: 10.1111/jan.12424. Epub 2014 Apr 15.
PubMed 24730753Askan F, Lafci Bakar D. The Effect of Hand Massage on Preoperative Anxiety Level and Hemodynamic Variables in Children: A Randomized Controlled Trial. J Perianesth Nurs. 2023 Oct;38(5):773-781. doi: 10.1016/j.jopan.2023.01.013. Epub 2023 Jul 15.
PubMed 37452817Demir B, Saritas S. Effect of hand massage on pain and anxiety in patients after liver transplantation: A randomised controlled trial. Complement Ther Clin Pract. 2020 May;39:101152. doi: 10.1016/j.ctcp.2020.101152. Epub 2020 Mar 21.
PubMed 32379634Cavdar AU, Yilmaz E, Baydur H. The Effect of Hand Massage Before Cataract Surgery on Patient Anxiety and Comfort: A Randomized Controlled Study. J Perianesth Nurs. 2020 Feb;35(1):54-59. doi: 10.1016/j.jopan.2019.06.012. Epub 2019 Sep 21.
PubMed 31551136Schaub C, Von Gunten A, Morin D, Wild P, Gomez P, Popp J. The Effects of Hand Massage on Stress and Agitation Among People with Dementia in a Hospital Setting: A Pilot Study. Appl Psychophysiol Biofeedback. 2018 Dec;43(4):319-332. doi: 10.1007/s10484-018-9416-2.
PubMed 30209712Gensic ME, Smith BR, LaBarbera DM. The effects of effleurage hand massage on anxiety and pain in patients undergoing chemotherapy. JAAPA. 2017 Feb;30(2):36-38. doi: 10.1097/01.JAA.0000510988.21909.2e.
PubMed 28098671Cino K. Aromatherapy hand massage for older adults with chronic pain living in long-term care. J Holist Nurs. 2014 Dec;32(4):304-13; quiz 314-5. doi: 10.1177/0898010114528378. Epub 2014 Apr 14.
PubMed 24733781Kudo Y, Sasaki M. Effect of a hand massage with a warm hand bath on sleep and relaxation in elderly women with disturbance of sleep: A crossover trial. Jpn J Nurs Sci. 2020 Jul;17(3):e12327. doi: 10.1111/jjns.12327. Epub 2020 Feb 3.
PubMed 32017413Yucel 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 30982141Koc M, Atar NY. The effect of hand massage on pain, comfort, and sleep quality in palliative care oncology patients. Support Care Cancer. 2026 Mar 12;34(4):308. doi: 10.1007/s00520-026-10558-5.
PubMed 41813939
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Hand Massage Applied to Palliative Care Oncology Patients on Pain, Comfort and Sleep Quality
- ClinicalTrials.gov ID
- NCT06360614
- Acronym / sponsor ID
- 2024s01
- Conditions
- Hand Massage
- Keywords
- Palliative care, Oncology, Hand massage, Pain, Comfort, Sleep quality
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 76 participants (actual)
- Lead sponsor
- murat koçOther government
- Collaborators
- Istanbul Sultanbeyli State Hospital
- Study start
- 15 May 2024 (actual)
- Primary completion
- 20 Jun 2025 (actual)
- Study completion
- 19 Jul 2025 (actual)
- First posted
- 11 Apr 2024 (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.
World Health Organization (WHO) palliative care is defined as "an approach that aims to reduce or prevent suffering by early identification, evaluation and treatment of the physical, psychosocial and spiritual problems of patients and families accompanying life-threatening diseases, and thus to increase their quality of life." Palliative care is a multidisciplinary approach that provides appropriate health care for oncology patients, who have a wide variety of medical, functional, social and emotional needs. Pharmacological approaches are generally used in symptom management of palliative care patients. In addition to pharmacological approaches, non-pharmacological approaches are also preferred. Massage is a preferred intervention among professional nursing practices because it is reliable, has no side effects, has a direct effect on patients, and is easy to apply.
Massage is the stimulation of the skin, subcutaneous tissue, muscles, internal organs, metabolism, circulation and lymph systems for therapeutic purposes through mechanical and neural means. The presence of sufficient mechanoreceptors in the hands, which stimulate painless nerve endings, shows that the hands should be chosen as the appropriate area for massage. Among the effects of hand massage: ensuring the regeneration of cells, facilitating the elimination of accumulated toxins, providing relaxation, helping to reduce pain by facilitating the release of endorphins, helping to increase circulation, regulating respiratory functions, providing stress and anxiety control, creating a state of well-being, strengthening the immune system, increasing general comfort, improving sleep quality. is located. Studies in the literature have found that hand massage reduces anxiety levels, stress and agitation levels, pain levels, and increases comfort and sleep levels. As seen in the literature, the effectiveness of hand massage applied to different sample groups on anxiety, stress, agitation, pain, comfort and sleep parameters was evaluated. There are very few studies evaluating the effectiveness of hand massage applied to oncology patients. In addition, no study has been found that evaluated the effects of hand massage on pain, comfort and sleep in palliative oncology patients, who constitute the majority of palliative care patients.
Detailed description
There is a rapid increase in cancer incidence and mortality worldwide. The International Agency for Research on Cancer (IARC) 2018 found that 18.1 million individuals were diagnosed with cancer worldwide. Individuals diagnosed with cancer experience many symptoms during the disease process, during the treatment phase, and in the terminal period. In most patients, many symptoms such as pain, insomnia, nausea and vomiting, anorexia, shortness of breath and fatigue are frequently observed, depending on the type and stage of cancer, treatments applied and accompanying diseases. Failure to control these symptoms affects the treatment process and may cause patients and family members to experience difficulties in the fight against cancer. During this period, the most effective way to meet all the needs of the patient and his family is to receive palliative care services. Palliative care is the key to individualized and holistic care. The scope of palliative care includes defining goals of care based on the patient's values and beliefs and addressing patients' physical, emotional, spiritual, and social problems. Palliative care is a multidisciplinary approach in which appropriate health care is provided for oncology patients, who have a wide range of medical, functional, social and emotional needs. Pharmacological approaches are generally used in symptom management of palliative care patients. In addition to pharmacological approaches, non-pharmacological approaches are also preferred. Practices such as reflexology, music therapy, acupuncture, aromatherapy, pet therapy, therapeutic touch, reiki, massage, hand massage therapy are non-pharmacological applications that can be used in palliative care oncology patients.
Massage is a preferred intervention among professional nursing practices because it is reliable, has no side effects, has a direct effect on patients, and is easy to apply. Massage is the stimulation of the skin, subcutaneous tissue, muscles, internal organs, metabolism, circulation and lymph systems for therapeutic purposes through mechanical and neural means . The presence of sufficient mechanoreceptors in the hands, which stimulate painless nerve endings, shows that the hands should be chosen as the appropriate area for massage. Hand massage application changes the sensation of pain in the neuromatrix. It increases the stimulation of large nerve fibers on the small C nerve fiber in the spinothalamic system through the spinal cord and reduces the sensation and transmission of pain by increasing blood flow to the hands. With the application of hand massage, sensory information is transferred from the hands to the spinothalamic pathway via the thalamus and somatosensory cortex via the spinal cord. While sensory information changes within the neuromatrix structure, it also reduces chronic pain. The scope of hand massage is limited, but it is a more accessible area. In addition, it can be applied more easily and conveniently than whole body massage due to its pain-reducing and comfort-increasing effect Among the effects of hand massage: ensuring the regeneration of cells, facilitating the elimination of accumulated toxins, providing relaxation, helping to reduce pain by facilitating the release of endorphins, helping to increase circulation, regulating respiratory functions, providing stress and anxiety control, creating a state of well-being, strengthening the immune system, increasing general comfort, improving sleep quality. Studies in the literature show that hand massage reduces anxiety levels, pain levels, stress and agitation levels; It has been stated that it is effective in increasing the level of comfort and sleep quality.
As seen in the literature, the effectiveness of hand massage applied to different sample groups on anxiety, stress, agitation, pain, comfort and sleep parameters was evaluated. There are very few studies evaluating the effectiveness of hand massage applied to oncology patients. In addition, no study has been found that evaluated the effects of hand massage on pain, comfort and sleep in palliative oncology patients, who constitute the majority of palliative care patients. Hand massage, which is a practical, safe and cost-free method in symptom management, which forms the basis of palliative care and has an important place in the treatment of oncology patients, should be used by evaluating its effectiveness.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Before the application, data will be collected and recorded through a face-to-face interview (8-10 minutes) by a nurse who does not know which group the patients are in. Sleep times of patients will be measured with a smart bracelet. At this stage, the same procedure will be continued for the intervention and control groups. Hand massage will be applied to the intervention group for 4 weeks, 2 days a week (Monday and Friday), 2 sessions each day. The control group will receive routine monitoring and nursing care for 4 weeks. In the intervention and control groups, VAS-Pain, General Comfort Scale and Pittsburgh Sleep Quality were assessed by a face-to-face interview by a nurse who did not know which group the patients were in, on the 7th day (Monday), 14th day (Monday) and 28th day (Monday). Index measurement tools will be applied and patients' sleep times will be measured with a smart bracelet.
| Arm | Type | Receives |
|---|---|---|
| Hand massage application | Experimental | Other: Hand massage applicationHand massage will be applied to the intervention group for 4 weeks, 2 days a week (Monday and Friday), 2 sessions each day. |
| Control Group | Placebo comparator | Other: routine monitoring and nursing careThe control group will receive routine monitoring and nursing care for 4 weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Oncology patients receiving treatment for at least 2 weeks in palliative care.
- 18 years and over.
- Able to communicate clearly and effectively.
- Visual Analogue Scale-Pain score above 3.
- Pittsburgh Sleep Quality Index score above 5.
Key exclusion criteria (8 listed)
- Less than 2 weeks of treatment in palliative care.
- Under 18 years of age.
- Outside the clinical protocol use analgesic medication or methods.
- A change in the standard protocol for pain and sleep.
- Visual Analogue Scale-Pain score below 3.
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 |
|---|---|---|
| Hand massage application2 sessions of hand massage every day, 2 days a week (Monday and Friday) for 4 weeks | Other | Hand massage application |
| routine monitoring and nursing careRoutine monitoring and nursing care for 4 weeks | Other | Control Group |
Primary outcome
İndividual Information Form
Time frame: 4 weeks
Prepared by the researcher in accordance with the purpose of the research. The Personal Information Form consists of questions about individuals' socio-demographic characteristics, pain and sleep patterns.
Patient Follow-up Form
Time frame: 4 weeks
It was prepared by the researcher in accordance with the purpose of the study. The Patient Monitoring Form allows recording of VAS-Pain, General Comfort Scale and Pittsburgh Sleep Quality Index scores evaluated on days 0, 7, 14 and 28.
General Comfort Scale
Time frame: 4 weeks
It is used to determine the needs in providing comfort and to evaluate the results of nursing interventions aimed at comfort. The General Comfort Scale, which is suitable for Turkish society by Kuğuoğlu and Karabacak (2004), is a four- and six-point Likert type, contains 24 positive and 24 negative items, and the response patterns are mixed. The highest total score to be obtained from the scale is 192, and the lowest total score is 48. The average value is determined by dividing the total score obtained by the number of scale items and the result is stated as 20 in the 1-4 distribution. Thus, the comfort level; Low comfort is expressed in a range of one point and high comfort is expressed in a range of four points. As a result of the Turkish validity-reliability study of GKS, it was found that the reliability of the scale was high (Cronbach's alpha = 0.85).
Pittsburgh Sleep Quality Index
Time frame: 4 weeks
The validity and reliability study of the scale in our country (Cronbach Alpha = 0.80) was conducted by Ağargün et al. in 1996. PSQI, which evaluates sleep quality in the last month, contains a total of 24 questions. 19 of these are self-report questions and are answered by the patient, while 5 questions are answered by a spouse or a roommate and are used only for clinical information and are not included in scoring. The scale consists of seven components: Subjective Sleep Quality, Sleep Latency, Sleep Duration, Sleep Efficiency, Sleep Disorder, Sleeping Medication Use, and Daytime Dysfunction. In the scale scoring, Subjective Sleep Quality, Sleep Duration and Sleeping Medication Use components are scored between 0-3 depending on the answer given. The total score obtained varies between 0-21 points, and high scores indicate poor sleep quality and high level of sleep disturbance. A total score of 5 or more from the scale indicates that sleep quality is significantly poor.
Smart Bracelet
Time frame: 4 weeks
Recording sleep/wake data of patients receiving hand massage; Smart bracelets were used to monitor sleep quality and process. The smart bracelet tracks your sleep patterns and provides information such as the time you fell asleep, the time you woke up, how many times you woke up during the night, and how long it took you to fall asleep each time. The sleep time measured by the smart bracelet is accessed through applications installed on smartphones by the researcher. Xiaomi Smart band 8 Pro was used to measure sleep times. The calibration of the device was carried out monthly at Xiaomi authorized service.
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 23 Jul 2025.
- Background: PubMed 31822173Harris D. Safe and effective prescribing for symptom management in palliative care. Br J Hosp Med (Lond). 2019 Dec 2;80(12):C184-C189. doi: 10.12968/hmed.2019.80.12.C184.
- Background: PubMed 24730753Hokka M, Kaakinen P, Polkki T. A systematic review: non-pharmacological interventions in treating pain in patients with advanced cancer. J Adv Nurs. 2014 Sep;70(9):1954-1969. doi: 10.1111/jan.12424. Epub 2014 Apr 15.
- Background: PubMed 37452817Askan F, Lafci Bakar D. The Effect of Hand Massage on Preoperative Anxiety Level and Hemodynamic Variables in Children: A Randomized Controlled Trial. J Perianesth Nurs. 2023 Oct;38(5):773-781. doi: 10.1016/j.jopan.2023.01.013. Epub 2023 Jul 15.
- Background: PubMed 32379634Demir B, Saritas S. Effect of hand massage on pain and anxiety in patients after liver transplantation: A randomised controlled trial. Complement Ther Clin Pract. 2020 May;39:101152. doi: 10.1016/j.ctcp.2020.101152. Epub 2020 Mar 21.
- Background: PubMed 31551136Cavdar AU, Yilmaz E, Baydur H. The Effect of Hand Massage Before Cataract Surgery on Patient Anxiety and Comfort: A Randomized Controlled Study. J Perianesth Nurs. 2020 Feb;35(1):54-59. doi: 10.1016/j.jopan.2019.06.012. Epub 2019 Sep 21.
- Background: PubMed 30209712Schaub C, Von Gunten A, Morin D, Wild P, Gomez P, Popp J. The Effects of Hand Massage on Stress and Agitation Among People with Dementia in a Hospital Setting: A Pilot Study. Appl Psychophysiol Biofeedback. 2018 Dec;43(4):319-332. doi: 10.1007/s10484-018-9416-2.
- Background: PubMed 28098671Gensic ME, Smith BR, LaBarbera DM. The effects of effleurage hand massage on anxiety and pain in patients undergoing chemotherapy. JAAPA. 2017 Feb;30(2):36-38. doi: 10.1097/01.JAA.0000510988.21909.2e.
- Background: PubMed 24733781Cino K. Aromatherapy hand massage for older adults with chronic pain living in long-term care. J Holist Nurs. 2014 Dec;32(4):304-13; quiz 314-5. doi: 10.1177/0898010114528378. Epub 2014 Apr 14.
- Background: PubMed 32017413Kudo Y, Sasaki M. Effect of a hand massage with a warm hand bath on sleep and relaxation in elderly women with disturbance of sleep: A crossover trial. Jpn J Nurs Sci. 2020 Jul;17(3):e12327. doi: 10.1111/jjns.12327. Epub 2020 Feb 3.
- 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.
- Derived from this study: PubMed 41813939Koc M, Atar NY. The effect of hand massage on pain, comfort, and sleep quality in palliative care oncology patients. Support Care Cancer. 2026 Mar 12;34(4):308. doi: 10.1007/s00520-026-10558-5.
- Individual participant dataSharing planned: No
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Cesarean Section, Anxiety
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Office Massage Effects on HRV and Stress
Occupational Health, Autonomic Nervous System (ANS) Functioning and Mood State
Recruiting
Effect of Hand Massage on Chronic Kidney Disease Associated Pruritus in Patients Receiving Hemodialysis
Chronic Kidney Disease Associated Pruritus
Not yet recruiting
Therapeutic Outcomes of Using Complementary Hand-based Treatment in Diabetes
Diabetes Mellitus, Type 1
Recruiting
Hand Massage for Physical Restraint
Physical Restraints, Hand Massage
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.
Murat Koç principal investigator
Istanbul Sultanbeyli State Hospital
Nurdan Yalçın ATAR principal investigator
Saglik Bilimleri Universitesi
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hand massage application and routine monitoring and nursing care in people with Hand Massage, run by murat koç at 1 site in Turkey (Türkiye).
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 7 inclusion and 8 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 23 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). 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. Some participants in this study may receive a placebo. 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?
İndividual Information Form (time frame: 4 weeks). The study lists 5 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 NCT06360614, which also lists 11 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 23 Jul 2025.