The Effect of Hand Massage Applied to Palliative Care Oncology Patients

NCT06360614 | Completed

• 1 other identifier: 2024s01
• Study Type: interventional
• Target: 76
• Locations: 1 country
• Sites: 1

Brief 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 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.

Conditions

Hand Massage

Keywords

Palliative care; Oncology; Hand massage; Pain; Comfort; Sleep quality

Outcome Measures

Primary Outcomes (5)

• 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.

  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.

  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).

  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.

  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.

  4 weeks

Study Arms (2)

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.

Other: Hand massage application

Control Group

PLACEBO COMPARATOR

The control group will receive routine monitoring and nursing care for 4 weeks.

Other: routine monitoring and nursing care

Interventions

Hand massage application OTHER

2 sessions of hand massage every day, 2 days a week (Monday and Friday) for 4 weeks

Hand massage application

routine monitoring and nursing care OTHER

Routine monitoring and nursing care for 4 weeks

Control Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Oncology patients receiving treatment for at least 2 weeks in palliative care.
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• murat koç: lead
• Istanbul Sultanbeyli State Hospital: collaborator

Study Sites (1)

Sultanbeyli State Hospital

Istanbul, Istanbul, 34000, Turkey (Türkiye)

Location

Related Publications (10)

• 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.

  PMID: 31822173 BACKGROUND

• Hokka 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.

  PMID: 24730753 BACKGROUND

• Askan 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.

  PMID: 37452817 BACKGROUND

• Demir 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.

  PMID: 32379634 BACKGROUND

• Cavdar 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.

  PMID: 31551136 BACKGROUND

• Schaub 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.

  PMID: 30209712 BACKGROUND

• Gensic 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.

  PMID: 28098671 BACKGROUND

• Cino 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.

  PMID: 24733781 BACKGROUND

• Kudo 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.

  PMID: 32017413 BACKGROUND

• 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.

  PMID: 30982141 BACKGROUND

MeSH Terms

Conditions

Neoplasms; Pain; Sleep Initiation and Maintenance Disorders

Interventions

Nursing Care

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Intervention Hierarchy (Ancestors)

Patient Care; Therapeutics; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Murat Koç

  Istanbul Sultanbeyli State Hospital

  PRINCIPAL INVESTIGATOR

• Nurdan Yalçın ATAR

  Saglik Bilimleri Universitesi

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Investigator

Model Details: 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.

Study Record Dates

• First Submitted: April 7, 2024
• First Posted: April 11, 2024
• Study Start: May 15, 2024
• Primary Completion: June 20, 2025
• Study Completion: July 19, 2025
• Last Updated: July 23, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)