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Effects of Mouth-opening Training on the Maximum Interincisal Opening

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ClinicalTrials.gov Identifier: NCT03875118
Recruitment Status : Completed
First Posted : March 14, 2019
Last Update Posted : March 14, 2019
Sponsor:
Collaborator:
Yuan's General Hospital
Information provided by (Responsible Party):
Tsae Jyy, Wang, National Taipei University of Nursing and Health Sciences

Brief 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.


Condition or disease Intervention/treatment Phase
Oral Cancer Behavioral: The mouth-opening training with follow-up telephone calls program Behavioral: The mouth-opening training without follow-up telephone calls program Not Applicable

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 randomized clinical trial using repeated measures. A convenience sample of 68 oral cancer patients was recruited and randomly assigned to either the intervention or control group according to a list generated by the Random Allocation Software. 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. Data on MIO and mandibular function impairment were collected before surgery, at one-month, and three-months after discharge, 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).


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 68 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Supportive Care
Official Title: 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
Actual Study Start Date : June 18, 2012
Actual Primary Completion Date : March 31, 2014
Actual Study Completion Date : March 31, 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Oral Cancer

Arm Intervention/treatment
Experimental: The intervention group
Subjects in the intervention group 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.
Behavioral: The mouth-opening training with follow-up telephone calls program
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.

Active Comparator: The control group
Subjects in the control group also 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.
Behavioral: The mouth-opening training without follow-up telephone calls program
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.




Primary Outcome Measures :
  1. TheraBite Range-of-Motion scale [ Time Frame: Change from Baseline to 3 months ]
    The TheraBite Range-of-Motion Scale was used to measure MIO with the patient in an upright position. MIO was measured as the maximal vertical distance between the edges of the incisors of the maxilla and the mandible. Subjects with MIO <35 mm were considered to have trismus.


Secondary Outcome Measures :
  1. Mandibular Function Impairment Questionnaire [ Time Frame: Change from Baseline to 3 months ]
    The MFIQ was used to measure the extent of patients' mandibular function impairment. The questionnaire consists of 17 items, each of which targets a specific oral function impairment; including difficulties in social activity, speech, taking a large bite, chewing hard food, chewing soft food, work and/or daily activities, drinking, laughing, chewing resistant food, yawning, kissing, and eating different types of food. The subjects were asked to indicate how much difficulty they had with each activity or with eating each type of food using a 5-point Likert scale (0 = no difficulty, 4 = very difficult or impossible without help). The total score of the 17 items divided by 68 provides the scale score, with a possible range of 0 to 1. A higher score indicates greater severity of the mandibular function impairment. A score ≤0.3, between 0.3 and 0.6, and >0.6 indicates mild, moderate, and severe mandibular function impairment, respectively.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. aged 18 years or older
  2. diagnosed with oral cancer
  3. scheduled for a primary curative oral cancer surgery
  4. able to communicate in Mandarin or Taiwanese
  5. obtained medical clearance from the patient's attending physician to participate in the study

Exclusion Criteria:

  1. diagnosed with lip or tongue cancers which were less relevant to trismus
  2. had central incisors extracted during the surgery

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03875118


Locations
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Taiwan
Yuan's General Hospital
Kaohsiung, Taiwan, 802
Sponsors and Collaborators
National Taipei University of Nursing and Health Sciences
Yuan's General Hospital
Investigators
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Principal Investigator: Tsae Jyy Wang, PhD National Taipei University of Nursing and Health Sciences

Publications:
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Responsible Party: Tsae Jyy, Wang, RN PhD Professor, National Taipei University of Nursing and Health Sciences
ClinicalTrials.gov Identifier: NCT03875118     History of Changes
Other Study ID Numbers: 20110818B
First Posted: March 14, 2019    Key Record Dates
Last Update Posted: March 14, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Tsae Jyy, Wang, National Taipei University of Nursing and Health Sciences:
Oral cancer
Trismus
Mouth-opening training
Jaw exercise
Additional relevant MeSH terms:
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Mouth Neoplasms
Head and Neck Neoplasms
Neoplasms by Site
Neoplasms
Mouth Diseases
Stomatognathic Diseases