The Effectiveness of Warm Hand Bath in Improving Anxiety
NCT ID: NCT06041672
Last Updated: 2023-12-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
78 participants
INTERVENTIONAL
2023-12-31
2025-06-30
Brief Summary
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Detailed Description
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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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
NONE
Study Groups
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Warm Water Hand Baths
Patients in the experimental group have their hand immersed in warm water (40°C) for ten minutes.
Warm Water Hand Baths
1. Patients in the experimental group receive warm water hand baths as an intervention on the evening before surgery.
2. The intervention is carried out in the patient's room, room temperature was adjusted to 26°C and the timing is determined based on the patient's preference.
3. The study utilizes a foldable water bucket with temperature maintenance capability.Patients in the experimental group have their hand immersed in warm water (40°C) for ten minutes in a comfortable lying position.
Routine care
Including preoperative instructions, postoperative care, and monitoring of vital signs.
No interventions assigned to this group
Interventions
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Warm Water Hand Baths
1. Patients in the experimental group receive warm water hand baths as an intervention on the evening before surgery.
2. The intervention is carried out in the patient's room, room temperature was adjusted to 26°C and the timing is determined based on the patient's preference.
3. The study utilizes a foldable water bucket with temperature maintenance capability.Patients in the experimental group have their hand immersed in warm water (40°C) for ten minutes in a comfortable lying position.
Eligibility Criteria
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Inclusion Criteria
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
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.
45 Years
ALL
Yes
Sponsors
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Cathay General Hospital
OTHER
Responsible Party
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Principal Investigators
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Yeu-Hui Chuang
Role: PRINCIPAL_INVESTIGATOR
Taipei Medical University
Central Contacts
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References
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Alghadir AH, Anwer S, Iqbal A, Iqbal ZA. Test-retest reliability, validity, and minimum detectable change of visual analog, numerical rating, and verbal rating scales for measurement of osteoarthritic knee pain. J Pain Res. 2018 Apr 26;11:851-856. doi: 10.2147/JPR.S158847. eCollection 2018.
Eberhart L, Aust H, Schuster M, Sturm T, Gehling M, Euteneuer F, Rusch D. Preoperative anxiety in adults - a cross-sectional study on specific fears and risk factors. BMC Psychiatry. 2020 Mar 30;20(1):140. doi: 10.1186/s12888-020-02552-w.
Gurler H, Yilmaz M, Turk KE. Preoperative Anxiety Levels in Surgical Patients: A Comparison of Three Different Scale Scores. J Perianesth Nurs. 2022 Feb;37(1):69-74. doi: 10.1016/j.jopan.2021.05.013. Epub 2021 Nov 19.
Gehrig LM. Orthopedic surgery. Am J Surg. 2011 Sep;202(3):364-8. doi: 10.1016/j.amjsurg.2011.06.007.
Greenstein AS, Gorczyca JT. Orthopedic Surgery and the Geriatric Patient. Clin Geriatr Med. 2019 Feb;35(1):65-92. doi: 10.1016/j.cger.2018.08.007. Epub 2018 Oct 11.
Kjaer N, Stabel S, Midttun M. Anti-osteoporotic treatment after hip fracture remains alarmingly low. Dan Med J. 2022 Sep 22;69(10):A01220010.
Konarski W, Pobozy T, Sliwczynski A, Kotela I, Krakowiak J, Hordowicz M, Kotela A. Avascular Necrosis of Femoral Head-Overview and Current State of the Art. Int J Environ Res Public Health. 2022 Jun 15;19(12):7348. doi: 10.3390/ijerph19127348.
Mulugeta H, Ayana M, Sintayehu M, Dessie G, Zewdu T. Preoperative anxiety and associated factors among adult surgical patients in Debre Markos and Felege Hiwot referral hospitals, Northwest Ethiopia. BMC Anesthesiol. 2018 Oct 30;18(1):155. doi: 10.1186/s12871-018-0619-0.
Ruiz Hernandez C, Gomez-Urquiza JL, Pradas-Hernandez L, Vargas Roman K, Suleiman-Martos N, Albendin-Garcia L, Canadas-De la Fuente GA. Effectiveness of nursing interventions for preoperative anxiety in adults: A systematic review with meta-analysis. J Adv Nurs. 2021 Aug;77(8):3274-3285. doi: 10.1111/jan.14827. Epub 2021 Mar 23.
Steghaus S, Poth CH. Assessing momentary relaxation using the Relaxation State Questionnaire (RSQ). Sci Rep. 2022 Sep 29;12(1):16341. doi: 10.1038/s41598-022-20524-w.
Tadesse M, Ahmed S, Regassa T, Girma T, Hailu S, Mohammed A, Mohammed S. Effect of preoperative anxiety on postoperative pain on patients undergoing elective surgery: Prospective cohort study. Ann Med Surg (Lond). 2021 Dec 22;73:103190. doi: 10.1016/j.amsu.2021.103190. eCollection 2022 Jan.
Tulloch I, Rubin JS. Assessment and Management of Preoperative Anxiety. J Voice. 2019 Sep;33(5):691-696. doi: 10.1016/j.jvoice.2018.02.008. Epub 2018 May 9.
Yamamoto K, Nagata S. Physiological and psychological evaluation of the wrapped warm footbath as a complementary nursing therapy to induce relaxation in hospitalized patients with incurable cancer: a pilot study. Cancer Nurs. 2011 May-Jun;34(3):185-92. doi: 10.1097/NCC.0b013e3181fe4d2d.
譚博謙. (2018). 探討足浴對女大學生焦慮及生理參數之作用. 南華大學自然生物科技學系自然療癒碩士班碩士論文，嘉義縣. 取自 https://hdl.handle.net/11296/gnsfhc
Other Identifiers
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CGH-P112023
Identifier Type: -
Identifier Source: org_study_id