Trial no.:
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PACTR201904716891248 |
Date of Approval:
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18/04/2019 |
Trial Status:
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Registered in accordance with WHO and ICMJE standards |
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TRIAL DESCRIPTION |
Public title
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Comparison of Conventional and Audiovisual Information on Anxiety and Postoperative Morbidity Following Third Molar Surgery: A Randomised Study. |
Official scientific title |
Comparison of Conventional and Audiovisual Information on Anxiety and Postoperative Morbidity Following Third Molar Surgery: A Randomised Study. |
Brief summary describing the background
and objectives of the trial
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Surgical extraction of impacted mandibular third molar (M3) is one of the commonest surgeries performed by the Oral and Maxillofacial surgeon. These surgeries are associated with post-operative inflammatory sequelae such as pain, swelling and trismus. These complications are a source of discomfort to patients and have been reported to cause a deterioration of quality of life in the immediate post-operative period and may account for days off work. The literature is replete with different studies on surgical and pharmacologic parameters that may ameliorate these postoperative discomforts. Little is however known about the social and psychological impact on the outcomes of oral surgical procedures. Research has reported that high levels of state and trait anxiety are associated with poorer postoperative recovery and the risks for complications. Information has also been shown to have impact on dental anxiety and may have impact on the post-operative complications. This information can be provided using multiple formats such as oral, written, audiovisual or combinations of two or more of these formats
The objectives of the study will be:
i. To determine the effect of conventional information on anxiety and postoperative outcomes.
ii. To determine the effect of audiovisual information on anxiety and postoperative outcomes.
iii. To compare the effects of conventional and audiovisual information on anxiety and postoperative outcomes
iv. To determine the effect of intraoperative factors on postoperative outcomes
v. To determine the interactions between the pre-operative and intra-operative factors and their impact on post-operative outcomes.
vi. To identify the sources of anxiety in patients undergoing third molar surgery.
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Type of trial |
RCT |
Acronym (If the trial has an acronym then please provide) |
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Disease(s) or condition(s) being studied |
Oral Health |
Sub-Disease(s) or condition(s) being studied |
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Purpose of the trial |
Treatment: Surgery |
Anticipated trial start date |
25/03/2019 |
Actual trial start date |
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Anticipated date of last follow up |
28/10/2019 |
Actual Last follow-up date |
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Anticipated target sample size (number of participants) |
90 |
Actual target sample size (number of participants) |
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Recruitment status |
Recruiting |
Publication URL |
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