- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07524179
Therapeutic Touch in Cancer Patients Receiving Palliative Care
The Effect of Therapeutic Touch on Sleep Quality and Fatigue Severity in Advanced Cancer Patients in the Palliative Care Setting: A Randomized Controlled Trial
Study Overview
Status
Intervention / Treatment
Detailed Description
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Merkez
-
Erzurum, Merkez, Turkey (Türkiye), 02040
- Erzurum City Hospital Palliative Care Service
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: therapeutic touch intervention group
Scales were applied to the intervention group in the first interview and pre-test data were obtained.
In the next process, therapeutic touch was performed to the intervention group for approximately 10-15 minutes on the head, shoulders, hands and feet starting at 22:00 at night for 5 days on weekdays within the scope of the research.
|
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.
|
|
Active Comparator: Control: Routine Palliative Care Group
Control group continued with routine palliative care protocols.
No therapeutic touch or other specific touch-based intervention was applied.
Scales were applied at the same time points as the intervention group.
|
Participants continued with routine palliative care protocols.
No therapeutic touch or other specific touch-based intervention was applied.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
Baseline and immediately after 5-day intervention
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
Baseline and immediately after 5-day intervention
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Neuroinflammatory Diseases
- Musculoskeletal Diseases
- Nervous System Diseases
- Muscular Diseases
- Pathologic Processes
- Encephalomyelitis
- Neuromuscular Diseases
- Chronic Disease
- Disease Attributes
- Pathological Conditions, Signs and Symptoms
- Signs and Symptoms
- Neoplasms
- Fatigue Syndrome, Chronic
- Fatigue
- Therapeutics
- Mind-Body Therapies
- Complementary Therapies
- Spiritual Therapies
- Therapeutic Touch
Other Study ID Numbers
- 27.03.2024-23396
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Cancer
-
Cellworks Group Inc.RecruitingCancer | Relapsed Cancer | Refractory CancerUnited States
-
Yale UniversityNational Institute of Nursing Research (NINR); The Glimpse Group IncRecruitingCancer | Adolescent Cancer | Young Adult CancerUnited States
-
University of Michigan Rogel Cancer CenterCompletedCancer Liver | Cancer Brain | Cancer Head &Neck | Cancer PelvisUnited States
-
Wake Forest University Health SciencesNational Cancer Institute (NCI); Atrium Health Wake Forest BaptistRecruitingCancer | Adolescent Cancer | Young Adult CancerUnited States
-
Vanderbilt-Ingram Cancer CenterEunice Kennedy Shriver National Institute of Child Health and Human Development... and other collaboratorsCompletedAdvanced Cancer | Relapsed Cancer | Refractory CancerUnited States
-
Second Affiliated Hospital of Soochow UniversityNot yet recruitingCancer | Solid Cancer
-
New Mexico Cancer Research AllianceOhio State University Comprehensive Cancer Center; H. Lee Moffitt Cancer Center...RecruitingCancer | Cancer RiskUnited States
-
Children's Hospital of PhiladelphiaCompletedCancer | Childhood CancerUnited States
-
City of Hope Medical CenterNational Cancer Institute (NCI)CompletedStage III Pancreatic Cancer | Stage IIA Pancreatic Cancer | Stage IIB Pancreatic Cancer | Stage IV Gastric Cancer | Stage IVA Colorectal Cancer | Stage IVA Pancreatic Cancer | Stage IVB Colorectal Cancer | Stage IVB Pancreatic Cancer | Stage IIIA Gastric Cancer | Stage IIIB Gastric Cancer | Stage IIIC Gastric... and other conditionsUnited States
-
UNICANCERRecruitingAdvanced Breast Cancer | Advanced Gastric Cancer | Advanced Urothelial Cancer | Advanced Non Small Cell Lung Cancer (NSCLC)France
Clinical Trials on Therapeutic Touch
-
Cukurova UniversityCompletedFatigue | Sleep | Menopause | Therapeutic TouchTurkey
-
Ayşe BelpınarCompletedPreterm Infants | Pain Management | Nasal Continuous Positive Airway PressureTurkey
-
Mardin Artuklu UniversityCompletedFatigue | Stress | SleepinessTurkey
-
Burdur Mehmet Akif Ersoy UniversityCompletedPain, Acute | Newborn | CryingTurkey
-
Dokuz Eylul UniversityCompletedPain, Acute | NewbornTurkey
-
Zehra BayramCompleted
-
Karamanoğlu Mehmetbey UniversityCompletedInfantile Colic | Therapeutic TouchTurkey
-
Cukurova UniversityCompletedComfort | Therapeutic Touch | Midwifery | Postpartum PeriodTurkey
-
Dilek GÜRÇAYIRCompletedIntraoperative ComplicationsTurkey
-
Cumhuriyet UniversityCompletedVaginal Delivery | First PregnancyTurkey (Türkiye)