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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:
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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Control | No Intervention | Patients in the control group received standard clinical care procedures and did not undergo a hot foot bath. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Warm water foot bath | Other | Keeping feet in 40oC (40 Degrees Celsius) warm water for 20 minutes |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Seher Ünver, Professor | Trakya University | Principal Investigator |
| Ülkü Çolakoğlu, BSN | Trakya University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Seher Ünver | Edirne | Edirne | 22030 | Turkey (Türkiye) |
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| ID | Term |
|---|---|
| D010911 | Pituitary Neoplasms |
| D001008 | Anxiety Disorders |
| ID | Term |
|---|---|
| D004701 | Endocrine Gland Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D007029 | Hypothalamic Neoplasms |
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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.
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The data analysed by a independent researcher The collected data was recorded on the form via an independent clinical nurse.
| oxygen saturation |
Patients' oxygen saturation was measured using an automated measuring device. |
| On the day of surgery, 1 hour before surgery |
| D015173 |
| Supratentorial Neoplasms |
| D001932 | Brain Neoplasms |
| D016543 | Central Nervous System Neoplasms |
| D009423 | Nervous System Neoplasms |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D007027 | Hypothalamic Diseases |
| D010900 | Pituitary Diseases |
| D004700 | Endocrine System Diseases |
| D001523 | Mental Disorders |