Clinical trial NCT06041672: The Effectiveness of Warm Hand Bath in Improving Anxiety
Official title: The Effectiveness of Warm Hand Bath in Improving Anxiety Before Lower Limbs Surgery Among Middle-aged and Older Patients
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Preoperative Anxiety
Keywords: lower limb bone surgery
warm water hand bath
preoperative anxiety
Lead sponsor: Cathay General Hospital
Sponsor class: OTHER
First posted: 2023-09-18
Enrollment: 78
Sex: ALL
Minimum age (years): 45
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Patients undergoing surgery often experience anxiety before the procedure. The aim of this study is to investigate the effectiveness of warm water baths in reducing preoperative anxiety levels in middle-aged and elderly patients undergoing lower limb orthopedic surgery. This study utilizes a randomized controlled trial design and focuses on middle-aged and elderly patients undergoing lower limb orthopedic surgery in the orthopedic ward of a medical center in northern Taiwan. The patients are divided into an experimental group and a control group using block randomization. Patients in the experimental group receive a 10-minute warm water bath at 40°C on the evening before surgery as an intervention, while the control group receives standard care. Data are collected from both groups before and after the intervention, including personal information, the State-Trait Anxiety Inventory, Visual Analog Scale for pain assessment, and Visual Analog Scale for relaxation, as well as vital sign measurements. Statistical analysis of the data is conducted using SPSS version 18.0 software, employing mean values, standard deviations, percentages, independent t-tests, chi-square tests, paired-sample t-tests, and generalized estimating equations for data analysis.

Detailed description: As the world's population ages, musculoskeletal surgeries have become a primary reason for surgery in elderly individuals, affecting 41.3% of elderly patients. Hospitalization and surgery can cause anxiety, and previous research has shown that the prevalence of preoperative anxiety in surgical patients is around 60-94%, with over 35% of cases experiencing high levels of anxiety. When patients experience preoperative anxiety, it can affect their postoperative recovery, including wound healing, functional recovery, the occurrence of complications, and increased length of hospital stay or recovery time. Early intervention to help patients relieve anxiety can reduce these negative effects. Current literature has shown that multimedia educational health education, music therapy, aromatherapy, massage, and other interventions can effectively reduce preoperative anxiety, but these interventions require professional training or the preparation of additional materials and equipment. In this study, a warm water hand bath was used as the intervention, mainly because lower limb surgery patients are not suitable for foot baths to achieve relaxation, and the operation of hand baths is simple, the equipment (warm water and basin) is easy to obtain, and patients or family members can easily learn to use it, making it convenient and accessible.Therefore, this study aims to understand how middle-aged and elderly participants who are about to undergo lower limb surgery can improve their preoperative anxiety, pain, and relaxation through the intervention of warm water hand baths.

After obtaining approval from the Taipei Cathay General Hospital Human Research Ethics Committee and registering on ClinicalTrials.gov, and obtaining consent from the Cathay Surgical Ward, the recruitment process began.

1. On the day of admission, subjects were recruited. Researcher (Principal Investigator ) personally introduced the study's purpose, recruitment procedure, and rights and obligations to eligible subjects. If the subjects expressed their willingness to participate, they were asked to sign an informed consent form.
2. Researcher used the admission time of the subjects as the recruitment time point. According to the order of subjects' admission, they were sequentially assigned to either the experimental group or the control group. An individual not involved in the study used a computer software program to generate serial numbers for randomization in blocks. The serial numbers and group assignments were placed in opaque envelopes with consecutive codes. After obtaining informed consent from the subjects, the envelopes were opened in sequence, and participants were assigned to the control or experimental group until a total of 78 subjects were recruited.
3. After knowing the subjects' group assignments, Researcher discussed the intervention time with the subjects. It was scheduled for the evening before the surgery, and subjects could choose a suitable time. The intervention took place in the subjects' hospital rooms.
4. Ten minutes before the warm water hand bath intervention, Researcher used the Braun ThermoScan® PRO 6000 ear thermometer and Omron HBP-1300 blood pressure monitor to measure vital signs (temperature, blood pressure, heart rate, respiration) and collected baseline questionnaire data. Questionnaires were administered on paper, and assistance was provided if subjects were unable to fill them out independently.
5. This study employed a foldable water bucket with temperature maintenance functionality for warm water hand baths. The water bucket did not require electricity but could maintain water temperature without it rising. Testing indicated that at room temperature (26°C), it could maintain water temperature for approximately 10 minutes. Subjects received the warm water hand bath the night before surgery, with the room temperature set at 26°C. If the subject's hospital room was not a single-person room, Researcher A negotiated the room temperature with adjacent patients. Four liters of 40°C warm water were added to the temperature-maintaining water bucket. To ensure temperature control, a floating LED water temperature monitor was used continuously. The monitor was the Dr.AV Saint Gok Technology-GE-53C Multi-Purpose Electronic Thermometer. If there was a drop in water temperature during the intervention, additional warm water was added to maintain the appropriate temperature. Due to potential pain and difficulty sitting up, subjects assumed a comfortable lying position with a blanket placed under their arm. The temperature-maintaining water bucket was placed on both sides of the bed, and Researcher A assisted the subjects in placing their hand into the water. The entire hand was immersed up to the wrist crease, approximately 5 centimeters, and soaked for ten minutes. After each use, subjects rinsed their hand thoroughly with clean water, followed by disinfection with 75% alcohol. After ensuring dryness, the equipment was stored to prevent potential alcohol-related hazards. The control group's room temperature was also adjusted to 26°C. Subjects assumed a comfortable lying position and received routine care, including preoperative instructions, postoperative care, and monitoring of vital signs.
6. Researcher conducted post-intervention measurements of vital signs (temperature, blood pressure, heart rate, respiration) and collected post-test questionnaire data for both groups.

Eligibility criteria: Inclusion Criteria:

1. Age must be forty-five years or older.
2. Individuals diagnosed by a physician with lower limb bone-related conditions and planning to undergo orthopedic surgery.
3. Must maintain clear consciousness and be able to communicate verbally.
4. Patients with heart disease or diabetes must seek the opinion of the attending physicians (Dr. Liu Zhe-wei and Dr. Chen Yi-zhi) before undergoing this intervention.
5. The study encompasses the following lower limb orthopedic surgeries:

Total joint replacement surgery, including knee and hip joint replacements. Revision surgery for joint replacements. Joint osteotomy correction surgery. Arthroscopic joint surgery. Open reduction and internal fixation surgery. Other surgeries related to lower limb musculoskeletal conditions.

Exclusion Criteria:

1. Patients with hand or wrist fractures.
2. Individuals with peripheral circulation abnormalities.
3. Patients with autonomic nervous system disorders who are taking anxiety-related medications.
4. Pregnant women.
5. Individuals with wounds, infections, swelling, or injuries on the skin of both palms, preventing immersion in water.
6. Those suffering from other major illnesses or scheduled for two or more surgeries.
7. Patients requiring physiological monitoring.
8. Individuals needing a catheter placed below the wrist.

Primary outcomes:
measure: State-Trait Anxiety Inventory,A-State,STAI-S
timeFrame: Baseline, before the intervention(T0)
measure: State-Trait Anxiety Inventory,A-State,STAI-S
timeFrame: Immediately following after the intervention(T1)
Secondary outcomes:
measure: The pain(Visual Analogue Scale, VAS)
timeFrame: Baseline, before the intervention(T0)
measure: The pain(Visual Analogue Scale, VAS)
timeFrame: Immediately following after the intervention(T1)
measure: The Relaxation (Visual Analogue Scale,VAS)
timeFrame: Baseline, before the intervention(T0)
measure: The Relaxation (Visual Analogue Scale,VAS)
timeFrame: Immediately following after the intervention(T1)
Other outcomes:
Locations:
Study officials:
affiliation: Taipei Medical University
name: Yeu-Hui Chuang
role: PRINCIPAL_INVESTIGATOR
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