The Efficacy of Mouth Exercise in Oral Cancer Patients After Receiving Surgery
NCT ID: NCT05227807
Last Updated: 2022-02-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
69 participants
INTERVENTIONAL
2012-07-07
2014-12-12
Brief Summary
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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.
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Detailed Description
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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).
Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
PREVENTION
SINGLE
Study Groups
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Control group
the control group received routine care.
Usual care
routine care including written mouth exercise instructions
Intervention group
Intervention develop from the theoretical framework of social cognition theory
mouth opening exercise
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.
Interventions
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mouth opening exercise
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.
Usual care
routine care including written mouth exercise instructions
Eligibility Criteria
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Inclusion Criteria
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
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)
18 Years
ALL
No
Sponsors
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Chang Gung Medical Foundation
OTHER
National Taipei University of Nursing and Health Sciences
OTHER
Responsible Party
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Tsae Jyy, Wang
professor
Principal Investigators
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SuFan Wu, Doctor
Role: STUDY_DIRECTOR
National Taipei University of Nursing and Health Sciences
Other Identifiers
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100-4007A3
Identifier Type: -
Identifier Source: org_study_id
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