Skip to main content
OpenTrials
Completed

NCT Number: NCT07247526

Effect of Foot Bath on Anxiety and Physiological Parameters

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.

Completed

Looking for future studies?

Notify Me

Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Warm Water Foot Bath

Other

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

Primary outcomes

  1. 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".

  2. 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".

  3. 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.

  4. heart rate

    Time frame: On the day of surgery, 1 hour before surgery

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

  5. 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.

  6. body temperature

    Time frame: On the day of surgery, 1 hour before surgery

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

  7. oxygen saturation

    Time frame: On the day of surgery, 1 hour before surgery

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

Sponsors and collaborators

Lead sponsor

Trakya University

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Nov 25, 2025
Registry last updated
Apr 21, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.