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NCT Number: NCT06249295

Postoperative Oral Cryotherapy in Sore Throat and Daily Life

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Chung Shan Medical University

Taichung, 40201, Taiwan

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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)

Primary outcomes

  1. 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

  1. daily life

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Chung Shan Medical University

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2024
Study completion
2025
First posted
Feb 8, 2024
Registry last updated
Mar 18, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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