Postoperative Oral Cryotherapy in Sore Throat and Daily Life

NCT06249295 | Completed

• 1 other identifier: CS1 21024
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

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.

Conditions

Sleep Apnea, Obstructive

Keywords

Obstructive sleep apnea syndrome; oral cryotherapy; pain; daily life

Outcome Measures

Primary Outcomes (1)

• sore throat

  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.

  up to 2 weeks

Secondary Outcomes (1)

• daily life

  up to 2 weeks

Study Arms (2)

Intervention group

EXPERIMENTAL

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).

Other: oral cryotherapy

control group

NO INTERVENTION

The control group received general routine care.

Interventions

oral cryotherapy OTHER

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)

Intervention group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• (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.

You may not qualify if:

• (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.

Sponsors & Collaborators

• Chung Shan Medical University: lead

Study Sites (1)

Chung Shan Medical University

Taichung, 40201, Taiwan

Location

MeSH Terms

Conditions

Sleep Apnea, Obstructive; Pain

Interventions

Cryotherapy

Condition Hierarchy (Ancestors)

Sleep Apnea Syndromes; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

• Hsiang Chu Pai, PhD

  Chung Shan Medical University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 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), while the control group received general routine care.

Study Record Dates

• First Submitted: January 30, 2024
• First Posted: February 8, 2024
• Study Start: January 31, 2024
• Primary Completion: January 31, 2024
• Study Completion: July 31, 2025
• Last Updated: March 18, 2026

Record last verified: 2025-02

Locations

TW (1)