Effect of Foot Bath on Pain, Sleep, and Comfort Levels After Abdominal Surgery

NCT07366567 | Not Yet Recruiting

• 1 other identifier: 2025/284
• Study Type: interventional
• Target: 96
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this study was to investigate the effects of foot bath application on pain level, comfort and sleep quality in the postoperative period. H1: Foot baths have a postoperative pain-reducing effect. H2: Foot baths have a postoperative comfort-enhancing effect. H3: Foot baths have a postoperative sleep-improving effect.

Conditions

Sleep; Pain, Postoperative

Keywords

pain; foot bath; sleep quality; comfort

Outcome Measures

Primary Outcomes (2)

• Pain level

  "Numerical rating scale" A score of 0 (zero) indicates no pain, while a score of 10 (ten) indicates unbearable pain.

  postoperative period (first day)

• sleep quality

  "The Richards-Campbell Sleep Questionnaire" Each item is scored on a visual analog scale from 0 to 100. Scores between 0 and 25 indicate very poor sleep, while scores between 76 and 100 indicate very good sleep.

  postoperative period (1st day)

Secondary Outcomes (1)

• Adverse effect

  during application and 12 hours of application.

Study Arms (2)

Experimental group (with Foot Bath Device Foot Bath Application (20 min, 41-42°C)

EXPERIMENTAL

Postoperative Preparation: The intervention will commence once the effects of anesthesia have subsided and initial mobilization (routinely 6-8 hours post-surgery) has been achieved. At approximately 9:00 PM, the patient's feet will be prepared by removing socks or adjusting anti-embolic stockings above the ankle . A visual and physical examination of the feet will be conducted to screen for contraindications such as pressure injuries, wounds, or discoloration. Foot Bath Intervention: The foot bath procedure will be performed using a disinfected device lined with single-use, watertight bags to ensure hygiene.The water temperature will be strictly maintained at 41-42°C, verified by a non-contact infrared digital thermometer. Both feet will be immersed in the device for a duration of 20 minutes. Post-intervention, the researcher will thoroughly dry the patient's feet and replace their socks or anti-embolic stockings. Any adverse events or side effects observed, recorded.

Other: Foot bath device

Control group Control group (Standard care (no foot bath procedure)

NO INTERVENTION

Patients in the control group will receive routine care. Patient Recruitment and Preoperative Phase: Patients admitted to the General Surgery department for abdominal surgery will be informed about the study on the morning of their procedure. Following the acquisition of both verbal and written informed consent, the Patient Information Form will be completed. To establish a baseline for sleep quality, the Richards-Campbell Sleep Questionnaire (RCSQ) will be administered preoperatively. No foot bath application will be in question for the patients in the control group. Data Collection and Conclusion: On the morning of the first postoperative day, the RCSQ, GKO (Visual Analog Scale/Global Quality Scale), and pain scores will be administered to evaluate the intervention's impact. The data collection process will conclude following these assessments.

Interventions

Foot bath device OTHER

On the day of surgery, patients will receive a foot bath between 9:00 PM and 10:00 PM. Any socks or clothing on both feet will be removed. The feet will be visually and manually examined to determine if they show any signs of illness (pressure ulcers, discoloration, wounds, etc.). The patient will be informed that the foot bath device is disinfected before each use and that water-tight bags will be placed around the device to prevent contact between the foot and the water to facilitate repeated use. The water temperature will be adjusted to 41-42°C using an infrared thermometer (non-contact digital thermometer). Both feet will be placed inside the foot bath device. The patient's feet will remain in the foot bath device for 20 minutes. After the foot bath, the patient's feet will be thoroughly dried with a towel, and the patient will be re-dressed in their existing socks or anti-embolic stockings. Any side effects/adverse reactions, etc., related to the foot bath will be questioned and

Experimental group (with Foot Bath Device Foot Bath Application (20 min, 41-42°C)

Eligibility Criteria

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

You may qualify if:

• who are hospitalized in the General Surgery Clinic,
• are on day 0 of surgery,
• volunteer to participate in the study,
• have no neuropsychiatric diagnosis and are not taking antipsychotic medications,
• are over 18 years of age,
• accept random selection,
• and undergo abdominal surgery.
• For the experimental group, all patients with no infectious diseases (shingles, fungal infections, eczema, warts, calluses), local infections (abscesses, etc.), open lesions/wounds, scar tissue, edema, hematomas, thrombophlebitis, deep vein thrombosis, lymphangitis, coagulation disorders, varicose veins, osteoporosis, osteomyelitis, hepatitis, degenerative joint diseases, neuropathy due to diabetes, toe deformities, recent fractures, dislocations, or ruptures of muscle fibers, tendons, or ligaments will be included in the sample.

You may not qualify if:

• patients who underwent multiple simultaneous surgeries along with abdominal surgery,
• those with postoperative complications such as delirium,
• those who underwent reoperation,
• those with a pain score \>7 because it could affect sleep levels,
• and those who received narcotic analgesics on postoperative day 0 due to pain will be excluded from the sample.

Sponsors & Collaborators

• Trakya University: lead

Study Sites (1)

Trakya University Hospital

Edirne, Cahit Arf Boulevard, 22030, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Pain, Postoperative; Pain; Sleep Initiation and Maintenance Disorders

Condition Hierarchy (Ancestors)

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

Study Officials

• ZEYNEP KIZILCIK ÖZKAN, Assoc.Prof

  Trakya University

  STUDY CHAIR

• Ayşe Nur Aktaş, Reg.Nurse

  Trakya University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

ZEYNEP KIZILCIK ÖZKAN, Assco.Prof

CONTACT

05056010101; zeynepozkan@trakya.edu.tr

Ayşe Nur Aktaş, Reg. Nurse

CONTACT

aysenuraktas24@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: None (Open Label)
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor

Model Details: Patients in the experimental group will receive a foot bath. Patients in the control group will not be intervened within the scope of the study.

Study Record Dates

• First Submitted: November 22, 2025
• First Posted: January 26, 2026
• Study Start: December 29, 2025
• Primary Completion (Estimated): December 30, 2026
• Study Completion (Estimated): December 30, 2026
• Last Updated: January 26, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)