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The Efficacy of Mouth Exercise in Oral Cancer Patients After Receiving Surgery

Primary Purpose

Head and Neck Neoplasms

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
mouth opening exercise
Usual care
Sponsored by
National Taipei University of Nursing and Health Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Head and Neck Neoplasms focused on measuring oral cancer, Trismus, Mouth-opening training, Maximum interincisal opening, Follow-up telephone calls, Mandibular function

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Over 18 years old
  2. have a clear consciousness
  3. can communicate in Mandarin and Taiwanese
  4. diagnosed by a doctor as primary oral cancer (including gums, the floor of the mouth, buccal mucosa, hard palate, and posterior molar area) and
  5. undergoing oral cancer tumor resection (including upper lymphatic removal) Those who have undergone skin flap reconstruction
  6. radiation and/or concurrent chemotherapy.

Exclusion Criteria:

  1. Poor wound healing after surgery and unable to perform the oral movement
  2. no incisor or the position of the incisor after surgery is replaced by a flap due to surgery, the maximum opening distance cannot be measured
  3. those with lip and tongue cancers that are less related to the closure of the teeth ( Or those who are physically unable to exercise)

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Experimental

    Arm Label

    Control group

    Intervention group

    Arm Description

    the control group received routine care.

    Intervention develop from the theoretical framework of social cognition theory

    Outcomes

    Primary Outcome Measures

    MIO( Maximum inter-incisal opening)
    With the disposable oral activity scale (The TheraBite Range-of-Motion Scales), patients are asked to open their mouths as wide as possible while sitting on a chair. The TheraBite Range-of-Motion Scale was used to measure MIO with the subject in an upright position. Subjects with MIO <35 mm were considered to have trismus. The scale was measured by mm. For all values of mouth opening from 20 to 50 mm.The higher the score, the mouth is open.

    Secondary Outcome Measures

    Restriction of Mouth Opening Questionnaire
    There are 10 questions in the questionnaire. The content includes the restriction on eating, speaking, cleaning, and inspection of the oral cavity. Each question is scored on a Likert scale with a score of 1-5. The average score of each question is the total score of the scale. The higher the score, the mouth is open. The higher the degree of restriction. Chinese translation version of the questionnaire, the expert validity of each question content validity index score is greater than 0.8, for oral cancer patients (n = 60) Cronbach's α is 0.96
    Mandibular Function Impairment Questionnaire
    There are 17 questions, including the difficulty of chewing hard and soft foods, taking a big bite of food, laughing, eating specific foods, social activities, speaking, etc. Each question is scored on the Likert scale of 0-4 points. The scores of each question are added and divided by 68 to convert to a total score of 0-1 points. The higher the score, the more severe the functional impairment.
    Exercise Time
    oral exercise practicing time recoded by participants by time of exercise. Time is calculated in minutes

    Full Information

    First Posted
    December 12, 2021
    Last Updated
    February 2, 2022
    Sponsor
    National Taipei University of Nursing and Health Sciences
    Collaborators
    Chang Gung Medical Foundation
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05227807
    Brief Title
    The Efficacy of Mouth Exercise in Oral Cancer Patients After Receiving Surgery
    Official Title
    The Efficacy of Mouth Exercise for Preventing Trismus in Oral Cancer Patients After Receiving Surgery and Radio or Chemotherapy
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    February 2022
    Overall Recruitment Status
    Completed
    Study Start Date
    July 7, 2012 (Actual)
    Primary Completion Date
    October 30, 2014 (Actual)
    Study Completion Date
    December 12, 2014 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    National Taipei University of Nursing and Health Sciences
    Collaborators
    Chang Gung Medical Foundation

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    PURPOSE: The purpose of the study was to investigate the efficacy of mouth-opening training with follow-up on 1st、3rd、6th months for reducing postoperative trismus in patients with oral cancer. METHODS: The study is a quasi-experimental design using repeated measures. 44 patients admitted at a general hospital in Taiwan for oral cancer surgery were recruited to the control group first then 38 patients were recruited to the intervention group. All subjects were instructed to practice mouth-opening exercises three times a day every day for three months and two telephone calls fellow up. Subjects in the intervention group received mouth-opening exercise adherence. Data on maximum interincisal opening and mandibular function impairment were collected before surgery, at one month, three months, and six months after radiotherapy, using the TheraBite Range-of-Motion scale and Mandibular Function Impairment Questionnaire, Restriction of Mouth Opening Questionnaire, and Difficulty of Food Intake.
    Detailed Description
    The purpose of the study was to investigate the effect of mouth-opening exercise training with follow-up telephone calls for preventing postoperative trismus in patients with oral cancer. The specific aims were to test the intervention effects on enhancing mouth-opening exercise practice, MIO, and mandibular function. We hypothesized that the intervention group would show 1) better adherence to mouth-opening exercises, 2) greater MIO, and 3) better mandibular function over time, compared to the control group. The study is a quasi-experimental design with repeated measures. A convenience sample of 44 oral cancer patients was recruited to control group the 38 patients was recruited to the intervention group Subjects in the control group received routine care including written mouth exercise instructions. Subjects in both groups received two 30-minute individual trainings on the mouth-opening exercises before discharge from the hospital. Patients in the experimental group were provided with two one-on-one oral exercise instruction courses after receiving the last two radiation treatments by nurse practitioner. Subjects in the intervention group received additional 2 follow-up phone calls from the interventionist to enhance mouth-opening exercise adherence. Data on MIO and mandibular function impairment were collected before surgery, at one-month, three-months and six month after radiotherapy, using the TheraBite Range-of-Motion scale and the Mandibular Function Impairment Questionnaire. The study was approved by the research ethics committee of the hospital where the data were collected. All statistical analyses were carried out using the SPSS statistical package version 20.0 (SPSS Inc., Chicago, IL, USA). Characteristics of the subjects were summarized by percentages, means, and standard deviations (SDs). Chi-squared tests or Fisher's exact tests and two independent samples t-tests were used to examine group baseline equivalency. Value changes of study outcomes (MIO and mandibular function impairment) and mouth-opening exercises performed from T1, T2, to T3 were expressed in two study groups. A general linear model was used to model these outcomes as a function of main group effect and main time effect. An interaction term (group difference by time) was added into each model to investigate the synergistic effect of the intervention with time. Both the stability analysis and the analysis of repeated relationships were performed by generalized estimation equations (GEE).

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Head and Neck Neoplasms
    Keywords
    oral cancer, Trismus, Mouth-opening training, Maximum interincisal opening, Follow-up telephone calls, Mandibular function

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Participant
    Allocation
    Non-Randomized
    Enrollment
    69 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Control group
    Arm Type
    Active Comparator
    Arm Description
    the control group received routine care.
    Arm Title
    Intervention group
    Arm Type
    Experimental
    Arm Description
    Intervention develop from the theoretical framework of social cognition theory
    Intervention Type
    Behavioral
    Intervention Name(s)
    mouth opening exercise
    Intervention Description
    The intervention group receives an oral exercise intervention, including a 30-minute individual training, a multimedia oral exercise education video along with a print education booklet, and three follow-up phone calls.
    Intervention Type
    Behavioral
    Intervention Name(s)
    Usual care
    Intervention Description
    routine care including written mouth exercise instructions
    Primary Outcome Measure Information:
    Title
    MIO( Maximum inter-incisal opening)
    Description
    With the disposable oral activity scale (The TheraBite Range-of-Motion Scales), patients are asked to open their mouths as wide as possible while sitting on a chair. The TheraBite Range-of-Motion Scale was used to measure MIO with the subject in an upright position. Subjects with MIO <35 mm were considered to have trismus. The scale was measured by mm. For all values of mouth opening from 20 to 50 mm.The higher the score, the mouth is open.
    Time Frame
    Change from pre-intervention and during the intervention on 2, 4, and 6 months
    Secondary Outcome Measure Information:
    Title
    Restriction of Mouth Opening Questionnaire
    Description
    There are 10 questions in the questionnaire. The content includes the restriction on eating, speaking, cleaning, and inspection of the oral cavity. Each question is scored on a Likert scale with a score of 1-5. The average score of each question is the total score of the scale. The higher the score, the mouth is open. The higher the degree of restriction. Chinese translation version of the questionnaire, the expert validity of each question content validity index score is greater than 0.8, for oral cancer patients (n = 60) Cronbach's α is 0.96
    Time Frame
    Change from pre-intervention and during the intervention on 2, 4, and 6 months
    Title
    Mandibular Function Impairment Questionnaire
    Description
    There are 17 questions, including the difficulty of chewing hard and soft foods, taking a big bite of food, laughing, eating specific foods, social activities, speaking, etc. Each question is scored on the Likert scale of 0-4 points. The scores of each question are added and divided by 68 to convert to a total score of 0-1 points. The higher the score, the more severe the functional impairment.
    Time Frame
    Change from pre-intervention and during the intervention on 2, 4, and 6 months
    Title
    Exercise Time
    Description
    oral exercise practicing time recoded by participants by time of exercise. Time is calculated in minutes
    Time Frame
    each week during the intervention

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Over 18 years old have a clear consciousness can communicate in Mandarin and Taiwanese diagnosed by a doctor as primary oral cancer (including gums, the floor of the mouth, buccal mucosa, hard palate, and posterior molar area) and undergoing oral cancer tumor resection (including upper lymphatic removal) Those who have undergone skin flap reconstruction radiation and/or concurrent chemotherapy. Exclusion Criteria: Poor wound healing after surgery and unable to perform the oral movement no incisor or the position of the incisor after surgery is replaced by a flap due to surgery, the maximum opening distance cannot be measured those with lip and tongue cancers that are less related to the closure of the teeth ( Or those who are physically unable to exercise)
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    SuFan Wu, Doctor
    Organizational Affiliation
    National Taipei University of Nursing and Health Sciences
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Plan to Share IPD
    No

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    The Efficacy of Mouth Exercise in Oral Cancer Patients After Receiving Surgery

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