Effects of Mouth-opening Training on the Maximum Interincisal Opening

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Brief Title

Effects of Mouth-opening Training on the Maximum Interincisal Opening

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

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.

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).

Study Type

Interventional

Primary Outcome

TheraBite Range-of-Motion Scale

Secondary Outcome

 Mandibular Function Impairment Questionnaire (MFIQ)

Condition

Oral Cancer

Intervention

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

Study Arms / Comparison Groups

 The intervention group
Description:  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.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status

Behavioral

Estimated Enrollment

68

Start Date

June 18, 2012

Completion Date

March 31, 2014

Primary Completion Date

March 31, 2014

Eligibility 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

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Tsae Jyy Wang, PhD, ,

Location Countries

Taiwan

Location Countries

Taiwan

Administrative Informations

NCT ID

NCT03875118

Organization ID

20110818B

Responsible Party

Principal Investigator

Study Sponsor

National Taipei University of Nursing and Health Sciences

Collaborators

 Yuan's General Hospital

Study Sponsor

Tsae Jyy Wang, PhD, Principal Investigator, National Taipei University of Nursing and Health Sciences

Verification Date

April 2021