NCT06373614

Brief Summary

Foot massage or bed bath will be applied to improve sleep quality and reduce fatigue levels of individuals with cancer.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
39

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 15, 2024

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 18, 2024

Completed
8 days until next milestone

Study Start

First participant enrolled

April 26, 2024

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 26, 2024

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 26, 2024

Completed
Last Updated

July 25, 2025

Status Verified

June 1, 2025

Enrollment Period

7 months

First QC Date

April 15, 2024

Last Update Submit

July 22, 2025

Conditions

Keywords

cancersleep qualityfatiguebed bathfoot massage

Outcome Measures

Primary Outcomes (2)

  • 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".

    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.

    In the study, the fatigue of the patients will be evaluated for 5 days in the evening, before the interventions.

Study Arms (3)

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.

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.

Other: bed bath

control

NO INTERVENTION

no intervention

Interventions

Interventions are to be performed in the evening before bedtime for 4 consecutive days.

foot massage

Interventions are to be performed in the evening before bedtime for 4 consecutive days.

bed bath

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Over 18 years,
  • illiterate,
  • diagnosed with cancer
  • volunteer to participate in the study

You may not qualify if:

  • unable to communicate verbally

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Health Sciences

Istanbul, Uskudar, Turkey (Türkiye)

Location

Related Publications (4)

  • 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.

    PMID: 37162156BACKGROUND
  • Richards K. Techniques for measurement of sleep in critical care. Focus Crit Care. 1987 Aug;14(4):34-40. No abstract available.

  • Schoonhoven 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.

  • Quattrin 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.

MeSH Terms

Conditions

NeoplasmsSleep Initiation and Maintenance DisordersFatigue

Condition Hierarchy (Ancestors)

Sleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System DiseasesMental DisordersSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: foot massage (intervention group) bed bath (intervention group) control (control group)
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 15, 2024

First Posted

April 18, 2024

Study Start

April 26, 2024

Primary Completion

November 26, 2024

Study Completion

December 26, 2024

Last Updated

July 25, 2025

Record last verified: 2025-06

Data Sharing

IPD Sharing
Will not share

ı want to share my research protocol after the publication.

Locations