CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 181 enrolled
Drug / intervention
Music Intervention +1 moreother
Likely dose
Not stated in record
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Search/NCT05285995
NCT05285995N/ACompleted

The Effect of Two Distraction Strategies in Reducing Preoperative Anxiety in Children:A Randomized Controlled Trial

Central South University·interventional·Posted Mar 18, 2022·Updated Mar 18, 2022

In Brief

A clinical study evaluating Music Intervention and The animation intervention for Attention-Distributing Strategies and Preoperative Anxiety. Completed, enrolled 181 participants across 1 site.

Detailed Summary

As a very threatening stressor, surgery often leads to strong psychological stress reactions in surgical patients before surgery, the most typical of which is anxiety. According to previous studies, more than 60% of children have severe anxiety during induction of anesthesia. Preoperative anxiety in children is not only significantly related to postoperative adverse physiological and psychological changes such as delirium during recovery from anesthesia, postoperative pain, and sleep disturbance, but also has a serious negative impact on their future study and life (such as timidity, nocturia, etc.), even for several years. Moreover, if the child is uncooperative, crying violently, and refuses to enter the operating room due to preoperative psychological stress, coercive measures are often adopted in clinical practice, which can easily cause harm to the physical and mental health of the child. Therefore, effective interventions to reduce pre-operative anxiety in children is an urgent need. At present, most researches adopt different interventions to improve the preoperative anxiety of children. Several studies have explored to the efficacy of psychological interventions and virtual reality exposure in reducing preoperative anxiety in children undergoing surgery,results suggest that these interventions can reduce preoperative anxiety and postoperative pain in children. Through toys and video games, researchers verified the effects of psychological preparation on perioperative stress, anxiety, and mood in children undergoing cardiac surgery. In addition, researchers also conducted specialized games, interest induction, childlike and diversified nursing methods to relieve preoperative anxiety in children. Although these interventions have achieved certain effects, the intervention strategies need professionals accompanied and special arrangements, there also exist problems such as time-consuming, labor-intensive, and limited audience, especially during the peak operation period. Attention distraction is an emotion regulation strategy commonly used in daily life, which actively separates the individual's attention from negative emotions and points to neutral or positive stimuli. Music and animation are the most common and affordable distraction strategies to reduce preoperative anxiety in children, but their effects are inconsistent. It is worth noting that Chow believe that the effect of the combination of audio and video is better than that of music intervention. Moreover, previous studies confirmed that when a mental image is experienced, there is an associated emotion that connects the feeling state with the mind and body leading to a physiologic change. Therefore, this study intends to use two distraction strategies (music and animation) in pediatric surgery patients to compare the effects of the two strategies on preoperative anxiety, anesthesia induction cooperation, vital signs, and to explore effective methods to improve preoperative anxiety in children. This study was a randomized controlled trial according to the CONSORT guidelines.Researchers recruited child patients(3-12 years) from a general tertiary hospital in Changsha, Hunan province, China. Researchers divided the subjects into three groups, animation group, music group and control group. The 181 patients recruited were randomized into three groups. Instruments, including preoperative anxiety,the degree of cooperation of children during anesthesia induction ,heart rate and blood pressure were assessed at the three moments: before entering the operating room (baseline T0), entering the operating room(T1), and before induction of anesthesia(T2). The repeated-measures analysis of variance were used to analyze the data.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesChina
Collaborators--

Timeline

N/ACompletedFinished
2020202120222023202420252026
First PostedMar 18, 2022
Enrollment StartApr 7, 2019
Primary CompletionJun 8, 2019
Study CompletionOct 6, 2019
TodayJul 2, 2026
Enrollment to primary: 2 monthsPosted 4.3 years ago

Interventions

Music Interventionother

Before the operation, subjects were asked to choose their favorite music to listen so as to reduce the anxiety before the operation and before the induction of anesthesia.

The animation interventionother

Before surgery, subjects were asked to choose their favorite cartoons to watch to reduce anxiety before surgery and induction of anesthesia.