Effect of Foot Bath on Anxiety and Physiological Parameters

NCT ID: NCT07247526

Last Updated: 2025-11-25

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-04-15
• Study Completion Date: 2025-12-31

Brief Summary

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

• H1: Foot bath applied before surgery reduces the state anxiety level of patients.
• H01: There is no difference between the preoperative mean arterial pressure of the patients in the foot bath applied study group and the control group.
• H02: There is no difference between the preoperative heart rate of the patients in the foot bath applied study group and the control group.
• H03: There is no difference between the preoperative respiratory rates of the patients in the foot bath applied study group and the control group.
• H04: There is no difference between the preoperative body temperatures of the patients in the foot bath applied study group and the control group.
• H05: There is no difference between the preoperative oxygen saturations of the patients in the foot bath applied study group and the control group.
• H06: There is no difference between the preoperative pain levels of the patients in the study group and the control group where foot bath was applied.

On the day of surgery, participants will be asked to keep their feet in 40 hot 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.

Detailed Description

Group allocation of the patients was done through using Random Allocation Software program and patients were allocated into two groups: the intervention group and the control group.

The study was planned in three stages. In the first stage, the researcher nurse visited the patients in the study and control groups, who had been admitted to the ward at least 1 day before the surgery and who would be transferred to the operating room within 1 hour, in the single-person ward room, and after explaining the purpose of the research, she obtained the verbal and written consent of the patients who agreed to participate in the research. The Patient Information Form was filled out by the researcher nurse and the patients' state and trait anxiety levels were evaluated using STAI. The physiological parameters of the patients were evaluated by another nurse working in the ward due to the single-blind application of the study, and the results were recorded in the 0th minute section of the Patient Monitoring Table. Patients' pain levels were evaluated with VAS and anxiety levels with VAS-A. For this purpose, patients were asked to mark their scores on the scale.

In the second stage, the patients in the study group were asked to stand in a sitting position on the edge of the bed with their feet hanging down. The tub of the device to be used in the hot water foot bath was filled with water to cover 4-5 fingers above the patient's ankles and the temperature was adjusted to 40°C. Patients were asked to soak their feet in water for 20 minutes. During the intervention period, the researcher nurse was in the opposite room to monitor sudden changes in the patient's condition. After 20 minutes, the patients were asked to take their feet out of the water and were allowed to dry their feet by wrapping a towel around them. Patients in the control group were asked to remain in a comfortable sitting position for 20 minutes and were allowed to rest. The patients did not undergo any procedure.

In the third stage, the state anxiety levels and physiological parameters of the patients in the study and control groups were evaluated by another nurse working in the ward due to the single-blind conduct of the research. The measurement results of physiological parameters were recorded in the 20th minute section of the Patient Monitoring Table in accordance with the group to which the patient belonged. Patients' pain levels were evaluated with VAS and anxiety levels with VAS-A. For this purpose, patients were asked to mark their scores on the scale. Trait anxiety level was not re-evaluated because it did not show any immediate change.

Conditions

Pituitary Adenoma; Surgery

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: SINGLE

Study Groups

Intervention Group

Participants in this study group will be asked to keep their feet in hot water at 40oC (40 degrees Celsius) for 20 minutes, 1 hour before the surgery, on the day of surgery.

Group Type: EXPERIMENTAL

Hot water foot bath

Intervention Type: OTHER

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

Control Group

Control Group Participants in this study group will receive standard service clinic procedure and will not receive a hot water foot bath.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Hot water foot bath

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

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Trakya University

OTHER

Sponsor Role: lead

Responsible Party

Seher Ünver

Professor Dr.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Seher Ünver, Assoc. Prof.

Role: PRINCIPAL_INVESTIGATOR

Trakya University

Ülkü Çolakoğlu, BSN

Role: PRINCIPAL_INVESTIGATOR

Trakya University

Locations

Seher Ünver

Edirne, Edirne, Turkey (Türkiye)

Site Status: RECRUITING

Countries

Turkey (Türkiye)

Central Contacts

Seher Ünver, Assoc. Prof.

Role: CONTACT

seherunver@trakya.edu.tr

+90 505 500 72 17

Ülkü Çolakoğlu, BSN

Role: CONTACT

ulkucolakoglu97@gmail.com

+90 531 826 96 65

Facility Contacts

Seher Ünver

Role: primary

seherunver@trakya.edu.tr

+90 5055007217

Ülkü Çolakoğlu

Role: backup

ulkucolakoglu97@gmail.com

+905318269665

Other Identifiers

2024/10

Identifier Type: -

Identifier Source: org_study_id