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Clinical Trials/NCT06249295
NCT06249295CompletedNot Applicable

The Efficacy of Postoperative Oral Cryotherapy in Sore Throat and Daily Life in Patients With Sleep Apnea

Chung Shan Medical University1 site in 1 country64 target enrollmentStarted: January 31, 2024Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
64
Locations
1
Primary Endpoint
sore throat

Study Overview

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 Design

Study Type
Interventional
Allocation
Non Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
Yes

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.

Arms & Interventions

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).

Intervention: oral cryotherapy (Other)

control group

No Intervention

The control group received general routine care.

Outcomes

Primary Outcomes

sore throat

Time Frame: 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 Outcomes

  • daily life(up to 2 weeks)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Hsiang Chu Pai

Principal Investigator

Chung Shan Medical University

Study Sites (1)

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