PatientsNCT06373614
The Effect of Foot Massage and Bed Bath on Individuals With Cancer
A study testing foot massage and bed bath in people with Patients, run by Saglik Bilimleri Universitesi at 1 site in Turkey (Türkiye).
Trial summary
Foot massage or bed bath will be applied to improve sleep quality and reduce fatigue levels of individuals with cancer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Patients
- What is being tested?
- foot massage and bed bath
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 39 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 26 Apr 2024to 26 Dec 2024
- 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
- Over 18 years,
- illiterate,
- diagnosed with cancer
- volunteer to participate in the study
Who cannot join
- unable to communicate verbally
- Patients who do not meet the inclusion criteria.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
University of Health Sciences
Istanbul, Uskudar
About this study
Official title: The Effect of Foot Massage and Bed Bath on Fatigue and Sleep Quality in Individuals With Cancer.
Foot massage or bed bath will be applied to improve sleep quality and reduce fatigue levels of individuals with cancer.
Read the detailed description
Foot massage provides relaxation of the body with rubbing movements applied to the feet. The bathroom was an important part of the individual's general hygienic care In addition, it also ensures the physical and psychological comfort, safety and well-being of the individual.Massage and bed bath are among the independent interventions of the nurse that help the individual to relax within the scope of the Nursing Regulation. This study was planned to determine the effect of foot massage and bed bath on fatigue and sleep level in individuals with cancer.
- Conditions
- Patients
- Being tested
- foot massage, bed bath
- Keywords
- cancer, sleep quality, fatigue, bed bath, foot massage
- Medical subject headings
- Neoplasms, Sleep Initiation and Maintenance Disorders, Fatigue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
foot massageOther
Interventions are to be performed in the evening before bedtime for 4 consecutive days.
bed bathOther
Interventions are to be performed in the evening before bedtime for 4 consecutive days.
| Study group | Role | What they receive |
|---|---|---|
| foot massage | Experimental | Foot massage will be applied for a total of 30 minutes, 15 on the right foot and 15 on the left foot. In order to move comfortably during the foot massage, non-allergenic baby oil will be used. This intervention will continue in the evenings for 4 days. Receives: Other: foot massage |
| bed bath | Experimental | Bed bath will be applied for a total of 30 minutes with cotton and warm water. This intervention will continue in the evenings for 4 days. Receives: Other: bed bath |
| control | No intervention | no intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
sleep quality
The effect of interventions on sleep will be measured. The Richard Cample Sleep Scale will be used for this. A score of "0-25" indicates "very poor sleep" and a score of "76-100" indicates "very good sleep".
Measured: In the study, the sleep quality of the patients will be evaluated for 5 days after the sleep.
fatigue
The effect of interventions on fatigue will be measured. Brief Fatigue Invantory; (BFI) will be used for this. Scoring the items are between "0" and "10", where "0" means not affected at all and "10" means affected at the highest level.
Measured: In the study, the fatigue of the patients will be evaluated for 5 days in the evening, before the interventions.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2024
- Study start26 Apr 2024
- Primary completion26 Nov 2024
- Study completion26 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for PatientsStudies of the same condition, open and under way.
- More trials run by Saglik Bilimleri UniversitesiThe sponsor's other registered studies.
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- foot massage (intervention group) bed bath (intervention group) control (control group)
- Masking
- None (open label)
- Enrolment
- 39 participants (actual)
Sponsor and investigators
- Lead sponsor
- Saglik Bilimleri Universitesi
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06373614
- Sponsor's protocol ID
- 2023/18
- Status last verified
- Jun 2025
- First submitted
- 15 Apr 2024
- Last updated
- 25 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: ı want to share my research protocol after the publication.
Publications
Mazloum SR, Rajabzadeh M, Mohajer S, Bahrami-Taghanaki H, Namazinia M. Comparing the Effects of Warm Footbath and Foot Reflexology on the Fatigue of Patients Undergoing Radiotherapy: A Randomized Clinical Trial. Integr Cancer Ther. 2023 Jan-Dec;22:15347354231172940. doi: 10.1177/15347354231172940.
PubMed 37162156Richards K. Techniques for measurement of sleep in critical care. Focus Crit Care. 1987 Aug;14(4):34-40. No abstract available.
PubMed 3650169Schoonhoven L, van Gaal BG, Teerenstra S, Adang E, van der Vleuten C, van Achterberg T. Cost-consequence analysis of "washing without water" for nursing home residents: a cluster randomized trial. Int J Nurs Stud. 2015 Jan;52(1):112-20. doi: 10.1016/j.ijnurstu.2014.08.001. Epub 2014 Aug 10.
PubMed 25173772Quattrin R, Zanini A, Buchini S, Turello D, Annunziata MA, Vidotti C, Colombatti A, Brusaferro S. Use of reflexology foot massage to reduce anxiety in hospitalized cancer patients in chemotherapy treatment: methodology and outcomes. J Nurs Manag. 2006 Mar;14(2):96-105. doi: 10.1111/j.1365-2934.2006.00557.x.
PubMed 16487421Kabuk A, Demirel U, Inangil D. The effectiveness of nursing interventions on fatigue and sleep quality in hospitalized cancer patients: the role of foot massage and bed bath. Support Care Cancer. 2026 Feb 5;34(3):169. doi: 10.1007/s00520-026-10386-7.
PubMed 41644843
Study at a glance
From the registry record, last updated by the sponsor on 25 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Foot Massage and Bed Bath on Fatigue and Sleep Quality in Individuals With Cancer.
- ClinicalTrials.gov ID
- NCT06373614
- Acronym / sponsor ID
- 2023/18
- Conditions
- Patients
- Keywords
- cancer, sleep quality, fatigue, bed bath, foot massage
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 39 participants (actual)
- Lead sponsor
- Saglik Bilimleri UniversitesiUniversity, hospital or other
- Study start
- 26 Apr 2024 (actual)
- Primary completion
- 26 Nov 2024 (actual)
- Study completion
- 26 Dec 2024 (actual)
- First posted
- 18 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.
Foot massage or bed bath will be applied to improve sleep quality and reduce fatigue levels of individuals with cancer.
Detailed description
Foot massage provides relaxation of the body with rubbing movements applied to the feet. The bathroom was an important part of the individual's general hygienic care In addition, it also ensures the physical and psychological comfort, safety and well-being of the individual.Massage and bed bath are among the independent interventions of the nurse that help the individual to relax within the scope of the Nursing Regulation. This study was planned to determine the effect of foot massage and bed bath on fatigue and sleep level in individuals with cancer.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- foot massage (intervention group) bed bath (intervention group) control (control group)
| Arm | Type | Receives |
|---|---|---|
| foot massage | Experimental | Other: foot massageFoot massage will be applied for a total of 30 minutes, 15 on the right foot and 15 on the left foot. In order to move comfortably during the foot massage, non-allergenic baby oil will be used. This intervention will continue in the evenings for 4 days. |
| bed bath | Experimental | Other: bed bathBed bath will be applied for a total of 30 minutes with cotton and warm water. This intervention will continue in the evenings for 4 days. |
| control | No intervention | –no intervention |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Over 18 years,
- illiterate,
- diagnosed with cancer
- volunteer to participate in the study
Key exclusion criteria (2 listed)
- unable to communicate verbally
- Patients who do not meet the inclusion criteria.
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 |
|---|---|---|
| foot massageInterventions are to be performed in the evening before bedtime for 4 consecutive days. | Other | foot massage |
| bed bathInterventions are to be performed in the evening before bedtime for 4 consecutive days. | Other | bed bath |
Primary outcome
sleep quality
Time frame: In the study, the sleep quality of the patients will be evaluated for 5 days after the sleep.
The effect of interventions on sleep will be measured. The Richard Cample Sleep Scale will be used for this. A score of "0-25" indicates "very poor sleep" and a score of "76-100" indicates "very good sleep".
fatigue
Time frame: In the study, the fatigue of the patients will be evaluated for 5 days in the evening, before the interventions.
The effect of interventions on fatigue will be measured. Brief Fatigue Invantory; (BFI) will be used for this. Scoring the items are between "0" and "10", where "0" means not affected at all and "10" means affected at the highest level.
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 25 Jul 2025.
- Background: PubMed 37162156Mazloum SR, Rajabzadeh M, Mohajer S, Bahrami-Taghanaki H, Namazinia M. Comparing the Effects of Warm Footbath and Foot Reflexology on the Fatigue of Patients Undergoing Radiotherapy: A Randomized Clinical Trial. Integr Cancer Ther. 2023 Jan-Dec;22:15347354231172940. doi: 10.1177/15347354231172940.
- Results publication: PubMed 3650169Richards K. Techniques for measurement of sleep in critical care. Focus Crit Care. 1987 Aug;14(4):34-40. No abstract available.
- Results publication: PubMed 25173772Schoonhoven L, van Gaal BG, Teerenstra S, Adang E, van der Vleuten C, van Achterberg T. Cost-consequence analysis of "washing without water" for nursing home residents: a cluster randomized trial. Int J Nurs Stud. 2015 Jan;52(1):112-20. doi: 10.1016/j.ijnurstu.2014.08.001. Epub 2014 Aug 10.
- Results publication: PubMed 16487421Quattrin R, Zanini A, Buchini S, Turello D, Annunziata MA, Vidotti C, Colombatti A, Brusaferro S. Use of reflexology foot massage to reduce anxiety in hospitalized cancer patients in chemotherapy treatment: methodology and outcomes. J Nurs Manag. 2006 Mar;14(2):96-105. doi: 10.1111/j.1365-2934.2006.00557.x.
- Derived from this study: PubMed 41644843Kabuk A, Demirel U, Inangil D. The effectiveness of nursing interventions on fatigue and sleep quality in hospitalized cancer patients: the role of foot massage and bed bath. Support Care Cancer. 2026 Feb 5;34(3):169. doi: 10.1007/s00520-026-10386-7.
- Individual participant dataSharing planned: No. ı want to share my research protocol after the publication.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing foot massage and bed bath in people with Patients, run by Saglik Bilimleri Universitesi 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 4 inclusion and 2 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 25 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. 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?
sleep quality (time frame: In the study, the sleep quality of the patients will be evaluated for 5 days after the sleep.). The study lists 2 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 NCT06373614, which also lists 5 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 25 Jul 2025.