The Effect of Two Distraction Strategies in Reducing Preoperative Anxiety in Children

NCT05285995 | Completed

• 1 other identifier: XWANG
• Study Type: interventional
• Target: 181
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Attention-Distributing Strategies; Preoperative Anxiety

Keywords

Attention-Distributing Strategies; Preoperative Anxiety; Child; Operation

Outcome Measures

Primary Outcomes (9)

• The change from T0(baseline) the scores of anxiety of change at T1( entering the operating room)

  The outcome 1 was measured by Modified Yale Preoperative Anxiety Scale-Short Form（mYPAS -SF),it is an observational behavioral medical scale, which can be used in surgical children to assess the preoperative anxiety level. mYPAS included 5 parts (mental state, language, emotional expression, arousal state, and dependence on parents).Each item of the scale corresponds to a different score. During the evaluation, the children's behaviors correspond to the corresponding items. The children's behaviors are divided into 1-4 grades or 1-6 grades. After conversion, the total score is 22.92-100 point. The lower the score, the lower the anxiety level of the child, and vice versa.

  T0(before entering the operating room )--T1(entering the operating room)

• The change from T1( entering the operating room)the scores of anxiety of change at T2(before induction of anesthesia)

  The outcome 1 was measured by Modified Yale Preoperative Anxiety Scale-Short Form（mYPAS -SF),it is an observational behavioral medical scale, which can be used in surgical children to assess the preoperative anxiety level. mYPAS included 5 parts (mental state, language, emotional expression, arousal state, and dependence on parents).Each item of the scale corresponds to a different score. During the evaluation, the children's behaviors correspond to the corresponding items. The children's behaviors are divided into 1-4 grades or 1-6 grades. After conversion, the total score is 22.92-100 point. The lower the score, the lower the anxiety level of the child, and vice versa.

  T1(entering the operating room)--T2(before induction of anesthesia)

• The degree of cooperation of children during anesthesia induction

  The outcome 2 was measured by the Induction Compliance Checklist , There are 11 items in total, with scores ranging from 0 to 10 points. A score of 0 points means that the induction was successful without any uncooperative behavior; 10 points mean that the induction failed, that is, the child was completely passive and the degree of cooperation was very poor. If the child has the same condition as the item on the scale, the child can get 1 point, and the points were added up to get the final total score. The lower the total score, the better the cooperation.

  T2(before induction of anesthesia)

• The change from T0(baseline) the heart rate of change at T1( entering the operating room)

  The evaluation heart rate was performed by the same portable electronic sphygmomanometer (OMRON HEM-7124). The vital signs in the operation room were measured by the same ECG monitor (Minray BeneView T8).The heart rate was measured by beats per minute.

  T0(before entering the operating room )--T1(entering the operating room)

• The change from T1( entering the operating room)the heart rate of change at T2(before induction of anesthesia)

  The evaluation heart rate was performed by the same portable electronic sphygmomanometer (OMRON HEM-7124). The vital signs in the operation room were measured by the same ECG monitor (Minray BeneView T8).The heart rate was measured by beats per minute.

  T1(entering the operating room)--T2(before induction of anesthesia)

• The change from T0(baseline) the systolic blood pressure of change at T1( entering the operating room)

  The evaluation systolic blood pressure was performed by the same portable electronic sphygmomanometer (OMRON HEM-7124). The vital signs in the operation room were measured by the same ECG monitor (Minray BeneView T8). The systolic blood pressure was measured by mmHg.

  T0(before entering the operating room )--T1(entering the operating room)

• The change from T1( entering the operating room)the systolic blood pressure of change at T2(before induction of anesthesia)

  The evaluation systolic blood pressure was performed by the same portable electronic sphygmomanometer (OMRON HEM-7124). The vital signs in the operation room were measured by the same ECG monitor (Minray BeneView T8).The systolic blood pressure was measured by mmHg.

  T1(entering the operating room)--T2(before induction of anesthesia)

• The change from T0(baseline) the diastolic blood pressure of change at T1( entering the operating room)

  The evaluation diastolic blood pressure was performed by the same portable electronic sphygmomanometer (OMRON HEM-7124). The vital signs in the operation room were measured by the same ECG monitor (Minray BeneView T8).The diastolic blood pressure was measured by mmHg.

  T0(before entering the operating room )--T1(entering the operating room)

• The change from T1( entering the operating room)the diastolic blood pressure of change at T2(before induction of anesthesia)

  The evaluation diastolic blood pressure was performed by the same portable electronic sphygmomanometer (OMRON HEM-7124). The vital signs in the operation room were measured by the same ECG monitor (Minray BeneView T8).The diastolic blood pressure was measured by mmHg.

  T1(entering the operating room)--T2(before induction of anesthesia)

Study Arms (3)

The music group

EXPERIMENTAL

In the music group, on the basis of the routine preoperative care, the preferred music was selected from the music library as the intervention content on the day of surgery according to the preference of the children in the 1-day preoperative visit. If there was no preference, the music was played randomly. During the intervention, the same multimedia audio system (Wanderer EDIFIER R1700BT) was used to play music for 30-40 minutes, the volume was controlled at 35-80dB, and adjusted in time according to the feedback of the children.

Other: Music Intervention

The animation group

EXPERIMENTAL

The children in animation group also chose their favorite cartoons as the intervention content on the basis of preoperative care. The same pad (Lenovo TB3-850F) was used to play pre-selected cartoons, and volume as the music group. During the intervention period, the children in intervention group were also accompanied by a nurse, who was also responsible for the implementation and maintenance of the intervention program.

Other: The animation intervention

The control group

NO INTERVENTION

No interventions except routine preoperative visits and conventional care were performed for the control group.

Interventions

Music Intervention OTHER

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 music group

The animation intervention OTHER

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

The animation group

Eligibility Criteria

• Age: 3 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• With age from 3 to 12 years old;
• Had normal mental, psychological and intellectual development;
• Must receive general anesthesia surgery;
• Must be volunteered to join the study.

You may not qualify if:

• Receive an emergency surgery;
• With unstable vital signs or critical illness.

Sponsors & Collaborators

• Central South University: lead

Study Sites (1)

The Third Xiangya Hospital of Central South University

Changsha, Hunan, 410013, China

Location

Related Publications (21)

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Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: All patients were screened by researchers for eligibility and then enrolled in the study if eligible and if they provided consent. We divided the subjects into three groups, animation group, music group and control group. According to the 1:1:1 balance of three groups, the statistician set the block length to 3, and carried out a random design of the single-blind block group. According to the sequence of the children entering the study, each group of 3 persons was randomly divided into 3 subjects in each block according to the random number table. The blind copy shall be kept by the personnel of the unit who have nothing to do with the experiment. The randomization plan will be saved by the statistician, and the researcher only has the number of each subject. After opening the envelope according to the number, they know whether the subject is the control group or the intervention group. Investigators involved in the intervention were not involved in the analysis of the study data.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Model Details: In the music group, on the basis of the routine preoperative care, the preferred music was selected from the music library as the intervention content on the day of surgery according to the preference of the children in the 1-day preoperative visit. If there was no preference, the music was played randomly. The children in animation group also chose their favorite cartoons as the intervention content on the basis of preoperative care. During the intervention period, the children in intervention group were also accompanied by a nurse, who was also responsible for the implementation and maintenance of the intervention program. The control group received routine care, which included routine preoperative visits and psychological comfort to the children.

Study Record Dates

• First Submitted: February 28, 2022
• First Posted: March 18, 2022
• Study Start: April 7, 2019
• Primary Completion: June 8, 2019
• Study Completion: October 6, 2019
• Last Updated: March 18, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)