Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT04978532 |
| Other study ID # |
Interventional |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
February 1, 2017 |
| Est. completion date |
October 21, 2018 |
Study information
| Verified date |
July 2021 |
| Source |
Biruni University |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
The study was conducted as a randomized controlled experimental trial. The children who
attended a pediatric surgical clinic for venipuncture divided into two groups via
randomization in the computer environment. After the randomization, the children in the
guided imagery group listened to a voice recording prepared in a studio during venipuncture.
This voice recording named 'Stroll in the Forest' helped the children to imagine that they
are strolling in a forest and guided them. On the other hand, no application was performed on
the children in the control group during the venipuncture. The primary outcome of the study
was pain and secondary outcomes were heart rate and oxygen saturation values. The pain was
evaluated by the children, parents, and observer. The pulse and oxygen saturation values were
measured before, during, and after the venipuncture.
Description:
Various nonpharmacological methods are used in reducing the pain of children. One of these
non-pharmacological methods is the guided imagery method. In the guided imagery method, the
imagination of children is used. It is possible to have children imagine by being guided with
audible stimulus and, therefore, distract their attention from the procedure or
pain/discomfort feeling. The aim of this study was to determine the effect of the guided
imagery method on procedural pain level, heart rate, and oxygen saturation values of the
children within the age range of 8-12 years. The sample size of the study has been determined
by the power analysis (G*Power 3.1.9.2), in line with the results obtained from the studies
which have been conducted using a similar research method. The sample size was found to be a
total of 144 children including minimum of 72 children for each group. It was estimated that
case losses may occur and therefore, it was decided to conduct the study with a total of 154
children including 77 children in two groups. One child in the guided imagery group was
excluded from the study as he/she gave up listening to voice recording during the procedure
and 1 child whose procedure could not be completed at once. In the control group, 1 child who
felt nauseous during the procedure and 1 child whose procedure could not be completed at once
could not be included in the sample group. Therefore, the sample group was composed of a
total of 150 children including 75 children in each group. Information Form, Faces Pain
Scale-Revised (FPS-R), and Visual Analogue Scale (VAS) were used for data collection.
Children and their parents who applied to the clinic for venipuncture were informed about the
study. information about children and their parents included in the study were asked by the
researcher through face-to-face interview and these data were recorded in 'Information Form'
ten minutes before the procedure. FPS-R was explained to the children and they were asked
whether or not they had pain before the procedure and they were asked to perform marking on
the scale. Also, the children were told that they would mark the pain score again after the
procedure. The parent was informed about 10-point VAS. Parent and observer (healthcare
professional) marked children's pain level on the VAS independently by using a ruler. The
researcher measured and recorded the pain level on the information form. The pulse oximeter
device was attached to the finger of the extremity of the child that was not used for blood
drawing. The children in the guided imagery group were informed that they would start to
listen to voice recording named 'Stroll in the Forest' before venipuncture and blood would be
drawn while they were listening to the voice recording. Also, children were asked to close
their eyes, imagine the text content, and focus on the voice recording while listening to the
voice. Thus, it was aimed to distract the children's attention from the procedure. One minute
before venipuncture, children wore an earphone and voice recording started. As routine
venipuncture procedure would be performed for the children in the control group, they were
informed about the venipuncture procedure. Pre-procedure heart rate and oxygen saturation
values of the children in the guided imagery group were determined and recorded just before
attachment of tourniquet at the 50th second of the voice recording and then tourniquet was
attached and blood drawing was started. Heart rate and oxygen saturation values of the
children in the control group before attaching the tourniquet were written and then
tourniquet was attached and then venipuncture was conducted. The blood of all the children
included in the study was drawn by the experienced laboratorian working in the clinic using
the 21 G needle-type injector. There was needle insertion in both control and guided imagery
groups and when the first blood was seen in injector, the heart rate and oxygen saturation
were recorded. Immediately after the injector was removed, the heart rate and oxygen
saturation were recorded. Just after the procedure, children were asked to mark the pain
level they felt during the procedure on FPS-R. The parent and observer evaluated the pain
level of the children during the procedure using VAS.
