Pituitary AdenomaNCT07247526
Effect of Foot Bath on Anxiety and Physiological Parameters
A study testing Warm water foot bath in people with Pituitary Adenoma and Surgery, run by Trakya University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Pituitary Adenoma, Surgery
- What is being tested?
- Warm water foot bath
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 25 Sep 2024to 5 Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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,
Show all 11Show fewer
- 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
Who cannot join
- 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,
Show all 11Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read more
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.
Read the 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.
- Conditions
- Pituitary Adenoma, Surgery
- Being tested
- Warm water foot bath
- Keywords
- foot, physiological parameters, anxiety
- Medical subject headings
- Pituitary Neoplasms, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Warm water foot bathOther
Keeping feet in 40oC (40 Degrees Celsius) warm water for 20 minutes
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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".
Measured: 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".
Measured: On the day of surgery, 1 hour before surgery
systolic and diastolic blood pressure
Patients' blood pressure was measured using an automated measuring device.
Measured: On the day of surgery, 1 hour before surgery
heart rate
Patients' heart rates were measured using an automated measuring device.
Measured: 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.
Measured: On the day of surgery, 1 hour before surgery
body temperature
Patients' body temperature was measured axillary using an automated measuring device.
Measured: On the day of surgery, 1 hour before surgery
oxygen saturation
Patients' oxygen saturation was measured using an automated measuring device.
Measured: On the day of surgery, 1 hour before surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Nov 2025
- Study start25 Sep 2024
- Primary completion5 Dec 2025
- Study completion5 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pituitary AdenomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Trakya University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Seher Ünver, Trakya University
- Investigators
- Seher Ünver, Professor, Principal investigator, Trakya UniversityÜlkü Çolakoğlu, BSN, Principal investigator, Trakya University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07247526
- Sponsor's protocol ID
- 2024/10
- Status last verified
- Nov 2025
- First submitted
- 31 Jul 2025
- Last updated
- 21 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 21 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Preoperative Warm Water Foot Bath on Anxiety Level and Physiological Parameters in Patients With Pituitary Adenoma
- ClinicalTrials.gov ID
- NCT07247526
- Acronym / sponsor ID
- 2024/10
- Conditions
- Pituitary Adenoma, Surgery
- Keywords
- foot, physiological parameters, anxiety
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Trakya UniversityUniversity, hospital or other
- Study start
- 25 Sep 2024 (actual)
- Primary completion
- 5 Dec 2025 (actual)
- Study completion
- 5 Dec 2025 (actual)
- First posted
- 25 Nov 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Foot-bath | Experimental | Other: Warm water foot bathPatients 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. |
| Control | No intervention | –Patients in the control group received standard clinical care procedures and did not undergo a hot foot bath. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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,
Key exclusion criteria (11 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Warm water foot bathKeeping feet in 40oC (40 Degrees Celsius) warm water for 20 minutes | Other | Foot-bath |
Primary outcome
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".
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".
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.
heart rate
Time frame: On the day of surgery, 1 hour before surgery
Patients' heart rates were measured using an automated measuring device.
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.
body temperature
Time frame: On the day of surgery, 1 hour before surgery
Patients' body temperature was measured axillary using an automated measuring device.
oxygen saturation
Time frame: On the day of surgery, 1 hour before surgery
Patients' oxygen saturation was measured using an automated measuring device.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Apr 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Seher Ünver, Professor principal investigator
Trakya University
Ülkü Çolakoğlu, BSN principal investigator
Trakya University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Warm water foot bath in people with Pituitary Adenoma and Surgery, run by Trakya University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Anxiety Level (time frame: On the day of surgery, 1 hour before surgery). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Apr 2026.