Effect of Foot Bath on Anxiety and Physiological Parameters

April 15, 2026 updated by: Seher Ünver, Trakya University

The Effect of Preoperative Warm Water Foot Bath on Anxiety Level and Physiological Parameters in Patients With Pituitary Adenoma

The aim of this study is to examine the effect of warm water foot bath applied before pituitary adenoma surgery on anxiety level and physiological parameters. The main hypotheses are:

  • H1 = Foot bath group patients have lower state anxiety than control group patients.
  • H2 = Foot bath group patients have lower anxiety than control group patients.
  • H3 = Foot bath group patients have lower pain levels than control group patients.
  • H4 = Foot bath group patients have lower mean arterial blood pressure than control group patients.
  • H5 = Foot bath group patients have lower heart rates than control group patients.
  • H6 = Foot bath group patients have lower respiratory rates than control group patients.
  • H7 = Foot bath group patients have higher body temperatures than
  • H8 = Foot bath group patients have higher oxygen saturation than control group patients.

On the day of surgery, participants will be asked to keep their feet in 40 warm water for 20 minutes, 1 hour before the surgery.

If there is a comparison group: Researchers will compare the control group to see if there are any differences in the patients' anxiety level and physiological parameters.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Phase One (Initial Assessment / E1) Study and Control Groups: The research nurse visited the patients in the study and control groups, who were admitted to the clinic at least one day before surgery and would be transferred to the operating room within one hour, in their single-person clinic rooms. After explaining the purpose of the study, the researcher obtained verbal and written consent from the patients who agreed to participate. Then, the patient completed the Patient Identification Form by asking them questions. Due to the double-blind nature of the study, the patients' situational and continuous anxiety levels, pain levels, and physiological parameters were assessed by another clinical nurse working in the clinic, and the results were recorded in the table on the form. The data obtained from this phase constituted the initial assessment (E1) results of the study. Then, the implementation phase of the study began.

Phase Two (Implementation Phase) Study Group: In this phase, the basin of the device to be used in the warm water foot bath was filled with water to a level covering 4-5 fingers above the patients' ankles, and the temperature was allowed to stabilize at 40°C. Afterward, patients sat with their feet dangling over the edge of the bed and kept their feet in the water for 20 minutes. During the procedure, a research nurse was present in the room to monitor any sudden changes in the patients' condition (e.g., dizziness, low blood pressure). After 20 minutes, the patients removed their feet from the water and dried them with paper towels.

Control group: In this phase, patients were asked to sit comfortably and rest in bed for 20 minutes. No procedure was performed on the patients.

Phase Three (Final Assessment / E2) Study and control group: In this phase, due to the blinding applied in the study, the situational anxiety levels, pain levels, and physiological parameters of the patients in both groups were assessed by another clinical nurse working in the clinic, and the results were recorded in the table on the form. The data obtained from this phase constituted the final assessment (E2) results of the study. The characteristic anxiety levels were not re-evaluated as they did not show instantaneous changes.

Study Type

Interventional

Enrollment (Actual)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Those who are over 18 years old,
  • Having a caregiver with him/her,
  • Those who will undergo elective pituitary adenoma surgery,
  • Those who were hospitalized at least one day before their surgery,
  • No known psychological problems,
  • Conscious, oriented and able to communicate verbally,
  • No known peripheral vascular disease,
  • Not having diabetes,
  • No open wounds on their feet,
  • Staying in a single room,
  • Patients who want to take a foot bath in 40 °C water

Exclusion Criteria:

  • Those who are under 18 years of age,
  • Without a caregiver,
  • Not undergoing elective pituitary adenoma surgery,
  • Not hospitalized at least one day before the surgery,
  • Having a known psychological problem,
  • Conscious, oriented and unable to communicate verbally,
  • Known peripheral vascular disease,
  • Having diabetes,
  • Having open wounds on their feet,
  • Staying in a double room,
  • Patients who do not want to take a foot bath in 40 °C water

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Foot-bath
Patients in the intervention group were instructed to keep their feet in 40°C (40 degrees Celsius) water for 20 minutes one hour before surgery on the day of the operation.
Other: Warm water foot bath
Keeping feet in 40oC (40 Degrees Celsius) warm water for 20 minutes
No Intervention: Control
Patients in the control group received standard clinical care procedures and did not undergo a hot foot bath.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Anxiety Level
Time Frame: On the day of surgery, 1 hour before surgery

Assessed using the STAI (State-Trait Anxiety Inventory) and VAS-A (Visual Analog Scale-Anxiety). The STAI consists of two subscales that assess situational and trait anxiety separately, totaling forty items (STAI-T and STAI-S); each subscale contains twenty items. Total scores on each scale range from 20 to 80; higher scores indicate a higher level of anxiety.

The VAS-A indicates anxiety levels on a scale of "0 - no anxiety at all" to "10 - very anxious".
On the day of surgery, 1 hour before surgery
Pain Levels
Time Frame: On the day of surgery, 1 hour before surgery
Pain was assessed using the VAS scale. The VAS scale indicates pain levels from "0 - no pain" to "10 - very severe pain".
On the day of surgery, 1 hour before surgery
systolic and diastolic blood pressure
Time Frame: On the day of surgery, 1 hour before surgery
Patients' blood pressure was measured using an automated measuring device.
On the day of surgery, 1 hour before surgery
heart rate
Time Frame: On the day of surgery, 1 hour before surgery
Patients' heart rates were measured using an automated measuring device.
On the day of surgery, 1 hour before surgery
respiratory rate
Time Frame: On the day of surgery, 1 hour before surgery
Respiratory rate was measured by observing and counting thoracic movements for one minute while the patients were at rest.
On the day of surgery, 1 hour before surgery
body temperature
Time Frame: On the day of surgery, 1 hour before surgery
Patients' body temperature was measured axillary using an automated measuring device.
On the day of surgery, 1 hour before surgery
oxygen saturation
Time Frame: On the day of surgery, 1 hour before surgery
Patients' oxygen saturation was measured using an automated measuring device.
On the day of surgery, 1 hour before surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Trakya University

Investigators

  • Principal Investigator: Ülkü Çolakoğlu, BSN, Trakya University
  • Principal Investigator: Seher Ünver, Professor, Trakya University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 25, 2024

Primary Completion (Actual)

December 5, 2025

Study Completion (Actual)

December 5, 2025

Study Registration Dates

First Submitted

July 31, 2025

First Submitted That Met QC Criteria

November 20, 2025

First Posted (Actual)

November 25, 2025

Study Record Updates

Last Update Posted (Actual)

April 21, 2026

Last Update Submitted That Met QC Criteria

April 15, 2026

Last Verified

November 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2024/10

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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.

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