Procedural PainNCT04978532
Effect of Guided Imagery Method on Procedural Pain in Children
A study testing Guided Imagery in people with Procedural Pain and Pain, Acute, run by Biruni University at 1 site in Turkey (Türkiye).
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. Read more about this study
- Who is it for?
- Ages 8 to 12 years
- Conditions the study is for
- Procedural Pain, Pain, Acute
- What is being tested?
- Guided Imagery
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Feb 2017to 21 Oct 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Speaking Turkish as a native speaker by children and parents,
- Being between the ages of 8 and 12,
- Not taking an analgesic, antipyretic, and anti-inflammatory drug within last 6 hours,
- Having body temperature at normal level (36.5-37.2⁰C),
- Having no disease that can cause chronic pain,
- Having no auditory, mental, and neurological disability that can affect their participation,
- Having no negative symptom-history during previous venipuncture,
- Having no allergy to strawberry included in the guided imagine text, and having no fear about forests and squirrels.
Who cannot join
- Not speaking Turkish as a native speaker by children and parents,
- Being younger than 8 years old and older than 12 years old,
- Taking an analgesic, antipyretic, and anti-inflammatory drug within last 6 hours,
- Having body temperature at a higher than normal level,
- Having a disease that can cause chronic pain,
- Having auditory, mental, and neurological disability that can affect their participation,
- Having negative symptom-history during previous venipuncture,
- Having allergy to strawberry included in the guided imagine text, and having fear about forests and squirrels.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Guided Imagery Method on Procedural Pain in Children: A Randomized Controlled Trial
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.
Read the detailed 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.
- Conditions
- Procedural Pain, Pain, Acute
- Being tested
- Guided Imagery, Control Group
- Keywords
- guided imagery, pain management, procedural pain, venipuncture
- Medical subject headings
- Pain, Procedural, Acute Pain, Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Guided ImageryOther
The children in the guided imagery group listened to a voice recording named 'Stroll in the Forest' before and during venipuncture. One minute before venipuncture, children wore an earphone and voice recording started. Children closed their eyes, imagined the text content, and focused on the voice recording while listening to the voice. It is a voice recording that helps the children in the guided imagery group to imagine that they are strolling in a forest and guides them.
Control GroupOther
No intervention was made in the children.
| Study group | Role | What they receive |
|---|---|---|
| Guided Imagery Group | Experimental | One minute before venipuncture and during venipuncture, the children in the guided imagery group listened to a voice recording prepared in a studio. This voice recording named 'Stroll in the Forest' helped the children to imagine that they are strolling in a forest and guided them. Receives: Other: Guided Imagery |
| Control Group | Other | No intervention was performed to reduce pain in the control group. Receives: Other: Control Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of pain from before venipuncture to after venipuncture (assessed by children)
Pain assessed by children with Faces Pain Scale-Revised (FPS-R). This self-report scale is used to determine the level of acute pain. This scale is suitable for the use of children in the age range of 4-16 years and it is a commonly preferred valid and reliable scale. The scale is composed of a total of 6 facial expressions, rated from 0 to 10, starting from a neutral face expression (0 point) and including a picture of a face expressing the existence of severe pain without tears (10 points).
Measured: Before venipuncture procedure and after venipuncture procedure (immediately after the injector was removed)
Change of pain from before venipuncture to after venipuncture (assessed by parents and the observer)
Pain assessed by parents and the observer with Visual Analog Scale (VAS). VAS is composed of a 100-mm horizontal line and the point "0" of this line expresses "no pain" and the point "10" expresses "worst pain". Firstly, the individual marks the intensity of the pain he/she perceives and the point marked by him/her is measured by using a ruler so that the pain score is determined
Measured: Before venipuncture procedure and after venipuncture procedure (immediately after the injector was removed)
Secondary outcomes (2)
Heart Rate
Fingertip 'Creative' pulse oximeter device calibrated to measure the heart rate value of the children was used.The heart rate of all the children in the guided imagery group and control group recorded before, during, and after the venipuncture procedure.
Measured: Before venipuncture procedure, during venipuncture procedure (when needle insertion and the first blood was seen in injector, until needle removed), and after venipuncture procedure (immediately after the injector was removed)
Oxygen Saturation
Fingertip 'Creative' pulse oximeter device calibrated to measure the oxygen saturation value of the children was used.The oxygen saturation of all the children in the guided imagery group and control group recorded before, during, and after the venipuncture procedure.
Measured: Before venipuncture procedure, during venipuncture procedure (when needle insertion and the first blood was seen in injector, until needle removed), and after venipuncture procedure (immediately after the injector was removed)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2021
- Study start1 Feb 2017
- Primary completion30 Mar 2018
- Study completion21 Oct 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Procedural PainStudies of the same condition, open and under way.
- More trials run by Biruni UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Biruni University
- Sponsor type
- University, hospital or other
- Collaborators
- Istanbul University
- Responsible party
- Principal investigator, Zeynep Erkut, Biruni University
- Investigators
- Zeynep Erkut, PhD, Principal investigator, Biruni UniversityDuygu Gözen, PhD, Principal investigator, Istanbul University Cerrahpaşa Florence Nightingale Faculty of Nursing
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04978532
- Sponsor's protocol ID
- Interventional
- Status last verified
- Jul 2021
- First submitted
- 3 Jul 2021
- Last updated
- 28 Jul 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Guided Imagery Method on Procedural Pain in Children: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04978532
- Acronym / sponsor ID
- Interventional
- Conditions
- Procedural Pain, Pain, Acute
- Keywords
- guided imagery, pain management, procedural pain, venipuncture
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Biruni UniversityUniversity, hospital or other
- Collaborators
- Istanbul University
- Study start
- 1 Feb 2017 (actual)
- Primary completion
- 30 Mar 2018 (actual)
- Study completion
- 21 Oct 2018 (actual)
- First posted
- 27 Jul 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Guided Imagery Group | Experimental | Other: Guided ImageryOne minute before venipuncture and during venipuncture, the children in the guided imagery group listened to a voice recording prepared in a studio. This voice recording named 'Stroll in the Forest' helped the children to imagine that they are strolling in a forest and guided them. |
| Control Group | Other | Other: Control GroupNo intervention was performed to reduce pain in the control group. |
Who may qualify
- Ages
- 8 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (8 listed)
- Speaking Turkish as a native speaker by children and parents,
- Being between the ages of 8 and 12,
- Not taking an analgesic, antipyretic, and anti-inflammatory drug within last 6 hours,
- Having body temperature at normal level (36.5-37.2⁰C),
- Having no disease that can cause chronic pain,
Key exclusion criteria (8 listed)
- Not speaking Turkish as a native speaker by children and parents,
- Being younger than 8 years old and older than 12 years old,
- Taking an analgesic, antipyretic, and anti-inflammatory drug within last 6 hours,
- Having body temperature at a higher than normal level,
- Having a disease that can cause chronic pain,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Guided ImageryThe children in the guided imagery group listened to a voice recording named 'Stroll in the Forest' before and during venipuncture. One minute before venipuncture, children wore an earphone and voice recording started. Children closed their eyes, imagined the text content, and focused on the voice recording while listening to the voice. It is a voice recording that helps the children in the guided imagery group to imagine that they are strolling in a forest and guides them. | Other | Guided Imagery Group |
| Control GroupNo intervention was made in the children. | Other | Control Group |
Primary outcome
Change of pain from before venipuncture to after venipuncture (assessed by children)
Time frame: Before venipuncture procedure and after venipuncture procedure (immediately after the injector was removed)
Pain assessed by children with Faces Pain Scale-Revised (FPS-R). This self-report scale is used to determine the level of acute pain. This scale is suitable for the use of children in the age range of 4-16 years and it is a commonly preferred valid and reliable scale. The scale is composed of a total of 6 facial expressions, rated from 0 to 10, starting from a neutral face expression (0 point) and including a picture of a face expressing the existence of severe pain without tears (10 points).
Change of pain from before venipuncture to after venipuncture (assessed by parents and the observer)
Time frame: Before venipuncture procedure and after venipuncture procedure (immediately after the injector was removed)
Pain assessed by parents and the observer with Visual Analog Scale (VAS). VAS is composed of a 100-mm horizontal line and the point "0" of this line expresses "no pain" and the point "10" expresses "worst pain". Firstly, the individual marks the intensity of the pain he/she perceives and the point marked by him/her is measured by using a ruler so that the pain score is determined
2 secondary outcomes
Heart Rate
Time frame: Before venipuncture procedure, during venipuncture procedure (when needle insertion and the first blood was seen in injector, until needle removed), and after venipuncture procedure (immediately after the injector was removed)
Oxygen Saturation
Time frame: Before venipuncture procedure, during venipuncture procedure (when needle insertion and the first blood was seen in injector, until needle removed), and after venipuncture procedure (immediately after the injector was removed)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jul 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Zeynep Erkut, PhD principal investigator
Biruni University
Duygu Gözen, PhD principal investigator
Istanbul University Cerrahpaşa Florence Nightingale Faculty of Nursing
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Guided Imagery in people with Procedural Pain and Pain, Acute, run by Biruni University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of pain from before venipuncture to after venipuncture (assessed by children) (time frame: Before venipuncture procedure and after venipuncture procedure (immediately after the injector was removed)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jul 2021.