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Completed

NCT Number: NCT07524179

Therapeutic Touch in Cancer Patients Receiving Palliative Care

This study aims to examine the effect of therapeutic touch applied to advanced cancer patients receiving palliative care on sleep quality and fatigue severity. This is a randomized controlled experimental study using a pretest-posttest design. The study includes advanced-stage cancer patients receiving support in a palliative care unit. Research data will be collected from patients between March and August 2024 using face-to-face interviews. The intervention group will receive therapeutic touch for 20 minutes per day for 5 consecutive days, while the control group will continue to receive routine palliative care. Data will be collected using a Personal Information Form, the Richards-Campbell Sleep Questionnaire (RCSQ), and the Fatigue Severity Scale (FSS).

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Key information

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Erzurum City Hospital Palliative Care Service

Erzurum, Merkez, 02040, Turkey (Türkiye)

About this study

Palliative care is a branch of healthcare that helps individuals who cannot achieve complete remission due to chronic diseases, mostly cancer, or who need care in the last period of life, to manage the multiple symptoms brought by the disease. The majority of cancer patients receiving palliative care treatment are in advanced cancer stages. The aim of treatment in cancer patients receiving palliative care is to improve quality of life and to manage pain, insomnia, fatigue, and other symptoms related to the disease. One of the most common problems experienced by these patients is insomnia and fatigue due to both treatment and the nature of the disease. These patients use many integrative methods as well as many medical treatments. One of these methods is therapeutic touch. The fact that this method has no known side effects makes it an attractive option for symptom management.

In the hospital setting, therapeutic touch can be applied in the patient's room and bed. After disinfecting the hands and bringing them to body temperature, the practitioner applies light, rhythmic touches to the patient's head, shoulders, arms, and feet. During this application, patients are asked to be in the most comfortable position. The therapeutic touch session for sleep, which is one of the variables of the study, should be performed close to the patient's bedtime (approximately 22:00). The application takes approximately 10-15 minutes.

Materials and Methods: The research is a randomized controlled experimental study with a pretest-posttest design. Randomization will be ensured by using a simple random number table.

Location of the Study: The study will consist of cancer patients receiving care and treatment services in the Palliative Care Service of Erzurum City Hospital, affiliated with the Ministry of Health of the Republic of Turkey.

Study Population and Sample Selection: Using G*Power 3.1.7 software, the sample size was calculated with a test power of 0.95. As a result of the analysis, it was determined that 30 patients should be included at the α=0.05 level, when the effect size was 0.10 and 95% power.

Implementation Protocol: After randomization, patients will be divided into two groups. Scales will be applied to the intervention group in the first interview and pretest data will be obtained. Therapeutic touch will be performed on the head, shoulders, hands, and feet for approximately 10-15 minutes, starting at 22:00, for 5 consecutive days.

Control Group: Patients in the control group will be interviewed at 22:00, and a sociodemographic questionnaire, the Richards-Campbell Sleep Questionnaire (RCSQ), and the Fatigue Severity Scale (FSS) will be administered. The data collection phase of the study will be completed by collecting posttest data from all groups after the last interview.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Inclusion Criteria:
  • 18 years of age or older
  • Pathologically confirmed advanced-stage cancer (stage 3-4)
  • Receiving palliative care treatment
  • Richards-Campbell Sleep Questionnaire (RCSQ) score ≤50
  • Fatigue Severity Scale (FSS) score ≥4
  • Mini-Mental Test score ≥24

Exclusion criteria

  • Known diagnosis of a major sleep disorder
  • Presence of acute infection
  • Widespread dermatological lesions compromising skin integrity (e.g., ulcer, eczema)
  • Dementia, delirium, or severe cognitive impairment
  • Hearing or vision loss that would hinder therapeutic communication
  • Medical condition that would contraindicate the application as determined by the palliative care team

Treatment and study plan

Therapeutic Touch

Behavioral

Therapeutic touch was applied to the head, shoulders, hands and feet for approximately 10-15 minutes per day for 5 consecutive days. The application was performed between 18:00-22:00 in the patient's room with privacy ensured. The protocol consisted of light, rhythmic touches based on the effleurage (stroking) technique.

Routine Palliative Care

Other

Participants continued with routine palliative care protocols. No therapeutic touch or other specific touch-based intervention was applied.

Primary outcomes

  1. Sleep Quality

    Time frame: Baseline and immediately after 5-day intervention

    Sleep quality measured by the Richards-Campbell Sleep Questionnaire (RCSQ). The scale consists of 5 items scored from 0 to 100. Higher scores indicate better sleep quality.

Secondary outcomes

  1. Fatigue Severity

    Time frame: Baseline and immediately after 5-day intervention

    Fatigue severity measured by the Fatigue Severity Scale (FSS). The scale consists of 9 items scored from 1 to 7. The total score is calculated by summing all item scores and dividing by 9. Higher scores indicate more severe fatigue.

Sponsors and collaborators

Lead sponsor

Erzurum Technical University

Other

Registry information

Official study title

The Effect of Therapeutic Touch on Sleep Quality and Fatigue Severity in Advanced Cancer Patients in the Palliative Care Setting: A Randomized Controlled Trial

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Apr 13, 2026
Registry last updated
Apr 13, 2026

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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