The Effect of Preoperative Warm Water Foot Bath on Anxiety Level and Physiological Parameters in Patients With Pituitary Adenoma
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- respiratory rate
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Double (Investigator, Outcomes Assessor)
盲法说明
The data analysed by a independent researcher The collected data was recorded on the form via an independent clinical nurse.
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Foot-bath
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.
干预措施: Warm water foot bath (Other)
Control
Patients in the control group received standard clinical care procedures and did not undergo a hot foot bath.
结局指标
主要结局
respiratory rate
时间窗: 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.
Pain Levels
时间窗: 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
时间窗: On the day of surgery, 1 hour before surgery
Patients' blood pressure was measured using an automated measuring device.
Anxiety Level
时间窗: 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".
Systolic and diastolic blood pressure
时间窗: On the day of surgery, 1 hour before surgery
Using an automatic measuring device, patients' systolic and diastolic blood pressure will be measured.
heart rate
时间窗: On the day of surgery, 1 hour before surgery
Patients' heart rates were measured using an automated measuring device.
body temperature
时间窗: On the day of surgery, 1 hour before surgery
Patients' body temperature was measured axillary using an automated measuring device.
oxygen saturation
时间窗: On the day of surgery, 1 hour before surgery
Patients' oxygen saturation was measured using an automated measuring device.
次要结局
未报告次要终点
研究者
Seher Ünver
Professor Dr.
Trakya University