CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 68 enrolled
Drug / intervention
The mouth-opening training with follow-up telephone calls program +1 morebehavioral
Likely dose
Not stated in record
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Search/NCT03875118
NCT03875118N/ACompleted
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Effects of Mouth-opening Training With Follow-up Telephone Calls on the Maximum Interincisal Opening and Mandibular Function of Postoperative Oral Cancer Patients: A Randomized Clinical Trial

National Taipei University of Nursing and Health Sciences·interventional·Posted Mar 14, 2019·Updated Apr 27, 2021

In Brief

A clinical study evaluating The mouth-opening training with follow-up telephone calls program and The mouth-opening training without follow-up telephone calls program for Oral Cancer. Completed, enrolled 68 participants across 1 site.

Detailed Summary

PURPOSE:The purpose of the study was to investigate the effect of mouth-opening training with follow-up telephone calls for reducing postoperative trismus in patients with oral cancer. METHODS:The study is a randomized clinical trial using repeated measures. Sixty-eight patients admitted at a general hospital in Taiwan for oral cancer surgery were recruited and randomly assigned to either the intervention or control group. All subjects were instructed to practice mouth-opening exercises three times a day every day for three months. Subjects in the intervention group received additional 6 follow-up phone calls to enhance mouth-opening exercise adherence. Data on maximum interincisal opening and mandibular function impairment were collected before surgery, at one-month, and three-months after discharge, using the TheraBite Range-of-Motion scale and Mandibular Function Impairment Questionnaire.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsOral Cancer
CountriesTaiwan
CollaboratorsYuan's General Hospital

Timeline

N/ACompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedMar 14, 2019
Enrollment StartJun 18, 2012
Primary CompletionMar 31, 2014
TodayJul 2, 2026
Enrollment to primary: 1.8 yearsPosted 7.3 years ago

Interventions

The mouth-opening training with follow-up telephone calls programbehavioral

Subjects in both groups received two 30-minute individual trainings on the mouth-opening exercises before discharge from the hospital. Subjects were instructed to practice the mouth-opening exercises three times a day, every day, for 12 weeks. Subjects in the intervention group received additional 6 follow-up phone calls (at 1, 2, 3, 4, 8 and 12-week after discharge) from the interventionist to enhance mouth-opening exercise adherence.

The mouth-opening training without follow-up telephone calls programbehavioral

Subjects in both groups received two 30-minute individual trainings on the mouth-opening exercises before discharge from the hospital. Subjects were instructed to practice the mouth-opening exercises three times a day, every day, for 12 weeks.