Trial Outcomes & Findings for Impact of Preanesthetic Information and Behavioral Intervention Using Smartphone on Anxiety of Children (NCT NCT02246062)
NCT ID: NCT02246062
Last Updated: 2016-01-07
Results Overview
The level of child's anxiety will be measure by modified Yale Preoperative Anxiety Scale (m-YPAS). The total score of m-YPAS was calculated according to what was originally proposed by Kain et al. The total scores range from 23,4 until 100. Cut-off scores to classify patients with or without anxiety were: without anxiety (23.4 - 30), with anxiety (\< 30).
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
84 participants
Primary outcome timeframe
24 hours before surgery
Results posted on
2016-01-07
Participant Flow
Participant milestones
| Measure |
Control Group
in which the relative receive only conventional verbal information one day before the procedure at ward.
|
Info Group
in which the relative, in addition to conventional verbal information, received a leaflet containing information about the anesthetic procedure one day before the surgery at ward.
info: the relative received leaflet containing information about the anesthetic procedure one day before the surgery at ward.
|
Smartphone Group
in which the relative received only conventional verbal information one day before the procedure and the child received smartphone application immediately before entering the operating room
smartphone: the child received smartphone application immediately before entering the operating room
|
Smartphone and Info Group
in which the relative, in addition to conventional verbal information, received a leaflet containing information about the anesthetic procedure one day before the surgery and the child received smartphone application immediately before entering the operating room.
info: the relative received leaflet containing information about the anesthetic procedure one day before the surgery at ward.
smartphone: the child received smartphone application immediately before entering the operating room
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
21
|
21
|
21
|
21
|
|
Overall Study
COMPLETED
|
21
|
21
|
21
|
21
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Impact of Preanesthetic Information and Behavioral Intervention Using Smartphone on Anxiety of Children
Baseline characteristics by cohort
| Measure |
Control Group
n=21 Participants
in which the relative receive only conventional verbal information one day before the procedure at ward.
|
Info Group
n=21 Participants
in which the relative, in addition to conventional verbal information, received a leaflet containing information about the anesthetic procedure one day before the surgery at ward.
info: the relative received leaflet containing information about the anesthetic procedure one day before the surgery at ward.
|
Smartphone Group
n=21 Participants
in which the relative received only conventional verbal information one day before the procedure and the child received smartphone application immediately before entering the operating room
smartphone: the child received smartphone application immediately before entering the operating room
|
Smartphone and Info Group
n=21 Participants
in which the relative, in addition to conventional verbal information, received a leaflet containing information about the anesthetic procedure one day before the surgery and the child received smartphone application immediately before entering the operating room.
info: the relative received leaflet containing information about the anesthetic procedure one day before the surgery at ward.
smartphone: the child received smartphone application immediately before entering the operating room
|
Total
n=84 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
5.29 years
STANDARD_DEVIATION 1.15 • n=93 Participants
|
5.45 years
STANDARD_DEVIATION 1.0 • n=4 Participants
|
5.29 years
STANDARD_DEVIATION 0.96 • n=27 Participants
|
5.65 years
STANDARD_DEVIATION 1.04 • n=483 Participants
|
5.41 years
STANDARD_DEVIATION 1.03 • n=36 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=93 Participants
|
9 Participants
n=4 Participants
|
7 Participants
n=27 Participants
|
2 Participants
n=483 Participants
|
25 Participants
n=36 Participants
|
|
Sex: Female, Male
Male
|
14 Participants
n=93 Participants
|
12 Participants
n=4 Participants
|
14 Participants
n=27 Participants
|
19 Participants
n=483 Participants
|
59 Participants
n=36 Participants
|
PRIMARY outcome
Timeframe: 24 hours before surgeryThe level of child's anxiety will be measure by modified Yale Preoperative Anxiety Scale (m-YPAS). The total score of m-YPAS was calculated according to what was originally proposed by Kain et al. The total scores range from 23,4 until 100. Cut-off scores to classify patients with or without anxiety were: without anxiety (23.4 - 30), with anxiety (\< 30).
Outcome measures
| Measure |
Control Group
n=21 Participants
in which the relative receive only conventional verbal information one day before the procedure at ward.
|
Info Group
n=21 Participants
in which the relative, in addition to conventional verbal information, received a leaflet containing information about the anesthetic procedure one day before the surgery at ward.
info: the relative received leaflet containing information about the anesthetic procedure one day before the surgery at ward.
|
Smartphone Group
n=21 Participants
in which the relative received only conventional verbal information one day before the procedure and the child received smartphone application immediately before entering the operating room
smartphone: the child received smartphone application immediately before entering the operating room
|
Smartphone and Info Group
n=21 Participants
in which the relative, in addition to conventional verbal information, received a leaflet containing information about the anesthetic procedure one day before the surgery and the child received smartphone application immediately before entering the operating room.
info: the relative received leaflet containing information about the anesthetic procedure one day before the surgery at ward.
smartphone: the child received smartphone application immediately before entering the operating room
|
|---|---|---|---|---|
|
Impact of Preanesthetic Information and Behavioral Intervention Using Smartphone Application on Anxiety of Children Measure by m-YPAS.
|
27.8 units on a scale m-YPAS
Standard Deviation 10.26
|
24.18 units on a scale m-YPAS
Standard Deviation 2.12
|
23.79 units on a scale m-YPAS
Standard Deviation 1.27
|
24.98 units on a scale m-YPAS
Standard Deviation 6.20
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Immediately before entering operation roomThe level of child's anxiety will be measure by modified Yale Preoperative Anxiety Scale (m-YPAS). The total score of m-YPAS was calculated according to what was originally proposed by Kain et al. The total scores range from 23,4 until 100. Cut-off scores to classify patients with or without anxiety were: without anxiety (23.4 - 30), with anxiety (\> 30).
Outcome measures
| Measure |
Control Group
n=21 Participants
in which the relative receive only conventional verbal information one day before the procedure at ward.
|
Info Group
n=21 Participants
in which the relative, in addition to conventional verbal information, received a leaflet containing information about the anesthetic procedure one day before the surgery at ward.
info: the relative received leaflet containing information about the anesthetic procedure one day before the surgery at ward.
|
Smartphone Group
n=21 Participants
in which the relative received only conventional verbal information one day before the procedure and the child received smartphone application immediately before entering the operating room
smartphone: the child received smartphone application immediately before entering the operating room
|
Smartphone and Info Group
n=21 Participants
in which the relative, in addition to conventional verbal information, received a leaflet containing information about the anesthetic procedure one day before the surgery and the child received smartphone application immediately before entering the operating room.
info: the relative received leaflet containing information about the anesthetic procedure one day before the surgery at ward.
smartphone: the child received smartphone application immediately before entering the operating room
|
|---|---|---|---|---|
|
Impact of Preanesthetic Information and Behavioral Intervention Using Smartphone Application on Anxiety of Children Measure m-YPAS.
|
31.88 units on a scale m-YPAS
Standard Deviation 13.94
|
23.88 units on a scale m-YPAS
Standard Deviation 2.18
|
25.85 units on a scale m-YPAS
Standard Deviation 6.44
|
25.93 units on a scale m-YPAS
Standard Deviation 9.05
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Immediately before induction of anesthesiaThe level of child's anxiety will be measure by modified Yale Preoperative Anxiety Scale (m-YPAS). The total score of m-YPAS was calculated according to what was originally proposed by Kain et al. The total scores range from 23,4 until 100. Cut-off scores to classify patients with or without anxiety were: without anxiety (23.4 - 30), with anxiety (\> 30).
Outcome measures
| Measure |
Control Group
n=21 Participants
in which the relative receive only conventional verbal information one day before the procedure at ward.
|
Info Group
n=21 Participants
in which the relative, in addition to conventional verbal information, received a leaflet containing information about the anesthetic procedure one day before the surgery at ward.
info: the relative received leaflet containing information about the anesthetic procedure one day before the surgery at ward.
|
Smartphone Group
n=21 Participants
in which the relative received only conventional verbal information one day before the procedure and the child received smartphone application immediately before entering the operating room
smartphone: the child received smartphone application immediately before entering the operating room
|
Smartphone and Info Group
n=21 Participants
in which the relative, in addition to conventional verbal information, received a leaflet containing information about the anesthetic procedure one day before the surgery and the child received smartphone application immediately before entering the operating room.
info: the relative received leaflet containing information about the anesthetic procedure one day before the surgery at ward.
smartphone: the child received smartphone application immediately before entering the operating room
|
|---|---|---|---|---|
|
Impact of Preanesthetic Information and Behavioral Intervention Using Smartphone Application on Anxiety of Children Measure by m-YPAS.
|
51.13 units on a scale m-YPAS
Standard Deviation 23.65
|
30.29 units on a scale m-YPAS
Standard Deviation 14.40
|
36.55 units on a scale m-YPAS
Standard Deviation 19.08
|
28.23 units on a scale m-YPAS
Standard Deviation 10.47
|
Adverse Events
Control Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Info Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Smartphone Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Smartphone and Info Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr Débora de Oliveira Cumino
Faculdade de ciências médicas da Santa Casa de São Paulo
Phone: +55 11 33617333
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place