Postoperative Oral Cryotherapy in Sore Throat and Daily Life

Not Applicable

Recruiting

• Conditions: Sleep Apnea, Obstructive
• Interventions: Other: oral cryotherapy

• Registration Number: NCT06249295
• Lead Sponsor: Chung Shan Medical University

Brief Summary

The purpose of this study will to evaluate the degree of postoperative sore throat and Life Impairment changes in patients with sleep apnea who underwent da Vinci robotic arm surgery as an intervention of oral cryotherapy.

Detailed Description

An experimental study was conducted with 32 patients in the experimental group and 32 patients in the control group. The experimental group used drinking water from a water dispenser with regular filter replacement and maintenance, plus a 2x5x7 cm (50 ml) ice lolly module to make ice lollies,and then intervened in the postsurgical period using oral cold therapy (ice lolly in the mouth),while the control group received general routine care. The control group received regular care. The assessment tools included the Pain Profile Scale and the Life Impairment Scale, and the assessment period was from the first day to the 14th day after the operation.

Study Timeline

• Study First Submitted: 2024-01-30
• Study Start: 2024-01-31
• Primary Completion: 2024-01-31
• Study First Submitted QC: 2024-02-06
• Study First Posted: 2024-02-08
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-10
• Last Update Posted: 2025-02-12
• Study Completion: 2025-07-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 64

Inclusion Criteria

• (1)Admission age is 18 years or above, conscious, able to communicate in Mandarin and Taiwanese, and willing to be measured and fill out the questionnaire after explaining the process and purpose of the study.
• (2) The study was conducted in hospitalised patients diagnosed with sleep apnea who underwent surgery.

Exclusion Criteria

• (1) Diagnostic diagnosis of the disease not clearly known.
• (2) Patients with unclear consciousness.
• (3) Patients who have been diagnosed with mental illness before the diagnosis of the -
• disease or recently diagnosed with mental illness.
• (4) People with paraplegia or low behavioural ability.
• (5) Patients who have suffered a stroke.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention group	oral cryotherapy	The experimental group used drinking water from a water dispenser with regular filter replacement and maintenance, plus a 2x5x7 cm (50 ml) ice lolly module to make ice lollies, and then intervened in the post-surgical period using oral cold therapy (ice lolly in the mouth).

Primary Outcome Measures

Name	Time	Method
sore throat	up to 2 weeks	The Pain Profile Scale assesses the pain level of the patient, which consists of 8 items: total pain level, throat pain level, throat pain during swallowing, ear pain during swallowing, difficulty swallowing, limitation of physical activity, oral odor, and sleep disruption, and other symptoms related to pain. The scoring criteria are based on a four-point scale: 0 for no sensation, 1 for mild, 2 for The scale is based on a four-point scale: 0 for no sensation, 1 for mild, 2 for moderate, and 3 for severe to present a multidimensional pain assessment.

Secondary Outcome Measures

Name	Time	Method
daily life	up to 2 weeks	The secondary outcome was to measure the extent to which the level of physical pain interfered with daily life, with a scale of 1 as not at all interfered, 2 as somewhat interfering, 3 as moderately interfering, 4 as considerably interfering, and 5 as extremely interfering, to understand the impact of pain on daily life.

Trial Locations

Locations (1)

Chung Shan Medical University; 🇨🇳 Taichung, Taiwan