Effect of Foot Bath on Anxiety and Physiological Parameters

NCT07247526 | Completed DMC

• 1 other identifier: 2024/10
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Pituitary Adenoma; Surgery

Keywords

foot; physiological parameters; anxiety

Outcome Measures

Primary Outcomes (7)

• Anxiety Level

  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

  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

  Patients' blood pressure was measured using an automated measuring device.

  On the day of surgery, 1 hour before surgery

• heart rate

  Patients' heart rates were measured using an automated measuring device.

  On the day of surgery, 1 hour before surgery

• respiratory rate

  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

  Patients' body temperature was measured axillary using an automated measuring device.

  On the day of surgery, 1 hour before surgery

• oxygen saturation

  Patients' oxygen saturation was measured using an automated measuring device.

  On the day of surgery, 1 hour before surgery

Study Arms (2)

Foot-bath

EXPERIMENTAL

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

Control

NO INTERVENTION

Patients in the control group received standard clinical care procedures and did not undergo a hot foot bath.

Interventions

Warm water foot bath OTHER

Keeping feet in 40oC (40 Degrees Celsius) warm water for 20 minutes

Foot-bath

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Trakya University: lead

Study Sites (1)

Seher Ünver

Edirne, Edirne, 22030, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Pituitary Neoplasms; Anxiety Disorders

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Hypothalamic Neoplasms; Supratentorial Neoplasms; Brain Neoplasms; Central Nervous System Neoplasms; Nervous System Neoplasms; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Hypothalamic Diseases; Pituitary Diseases; Endocrine System Diseases; Mental Disorders

Study Officials

• Seher Ünver, Professor

  Trakya University

  PRINCIPAL INVESTIGATOR

• Ülkü Çolakoğlu, BSN

  Trakya University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The data analysed by a independent researcher The collected data was recorded on the form via an independent clinical nurse.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor Dr.

Model Details: Experimental: Intervention Group Patients in the intervention group were instructed to keep their feet in 40°C (40 degrees Celsius) water for 20 minutes, 1 hour before surgery on the day of the operation. Intervention: Other: Warm water foot bath No Intervention: Control Group Patients in the control group received standard clinical procedures and did not undergo a warm water foot bath.

Study Record Dates

• First Submitted: July 31, 2025
• First Posted: November 25, 2025
• Study Start: September 25, 2024
• Primary Completion: December 5, 2025
• Study Completion: December 5, 2025
• Last Updated: April 21, 2026

Record last verified: 2025-11

Locations

TU (1)