PainNCT03720808
Venous Blood Sampling-Related Pain and Fear
A study testing Balloon Blowing, Ball Squeezing and Coughing in people with Pain and Fear, run by Çankırı Karatekin University at 1 site in Turkey (Türkiye).
Trial summary
This study is an experimental randomized controlled study conducted to compare the effect of balloon blowing, coughing, and ball squeezing methods applied during venous blood sampling from on pain and fear level in 7-12 year-old children. Read more about this study
- Who is it for?
- Ages 7 to 12 yearsHealthy volunteers can take part
- What is being tested?
- Balloon Blowing, Ball Squeezing and Coughing
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Mar 2017to 15 Nov 2017
- 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 7 to 12 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- The children,
- who were aged between 7-12 years,
- were healthy,
- did not receive any analgesic within the last 6 hours before venipuncture procedure,
- had no history of syncope during venipuncture procedure,
- agreed to participate in the study and gave the verbal and written consent.
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- Also, the parents were eligible for participation when meeting the following inclusion criteria:
- be healthy in terms of neurological functions,
- communicate verbally,
- understand and read Turkish,
- voluntarily sign the written informed consent.
Who cannot join
- The children;
- who had neuro-developmental disorder,
- could not communicate verbally,
- had hearing and visual impairment,
- suffered from acute pyretic disease,
- received topical anesthesia, took any analgesic within the last 6 hours before venipuncture procedure,
- had chronic disease requiring frequent venipuncture.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Comparison Of The Efficacy Of Three Methods Applied During Venous Blood Sampling On Reducing Pain And Fear In Children
This study is an experimental randomized controlled study conducted to compare the effect of balloon blowing, coughing, and ball squeezing methods applied during venous blood sampling from on pain and fear level in 7-12 year-old children. The population of the study consisted of all 7-12 year-old children who were referred to the blood-letting room for venous blood sampling in a state hospital. The sample of the study was determined as 120 children with confidence level of 95% and theoretical power of 95%. The children were divided into 4 groups of 30 people, including balloon blowing, ball squeezing, coughing, and control groups. Each intervention and control group was matched in terms of gender. In the study, the randomization of the sample group was performed by using stratification and block randomization methods.
Read the detailed description
The study is a randomized controlled, non-blinded, experimental trial. The population of the study consisted of all 7-12 year-old children who came to the venipuncture room in the state hospital.It is stated in the literature that the sample size should be determined as minimum 30 in both experimental and control groups in the experimental studies and parametric measurements. Therefore, in the study, each group included 30 children including three experimental groups and a control group and in the power analysis, power of the study was found as 0.95 at the confidence level of 95%. In order to prevent bias and increase the validity of the data, the pain and fear scores of the children before and after the procedure were assessed by three different groups as children participating in the study (n:120), their parents as the people who know the children best (n:120), and a researcher specialized in pediatric nursing (n:1), and the inter-observer agreement was examined. The level of pain was assessed by the Wong Baker Faces Scale and the fear of pain was assessed by the Children's Fear Scale.
In this experimental study, the children and their parents who came to the venipuncture room for venous blood sampling were evaluated in terms of the inclusion criteria and the children and parents who did not meet the criteria were excluded from the study. The children and parents complying with the inclusion criteria were informed about the study and their written and verbal consents were received. The children were included in one of the 4 study groups, including the balloon blowing, coughing, ball squeezing, and the control group without any intervention. In the studies, it was determined that gender had an important effect on evaluation of pain.39,40 In order to control the effect of gender on pain, the children were stratified into study groups based on their gender and selected by using block randomization method in four study groups. The children were randomized to the related study group by drawing one of the study groups in the cloth bags prepared for the girls (pink) and the boys (blue). Papers with the same color and folding pattern representing the four groups (1,2,3,4) were thrown in the bags. In order to provide a randomized distribution and to reduce all negative effects, the children were asked to take randomly a paper from the bag according to the gender after making the necessary explanation to the parents and their children so that the groups became self-balancing. A total of 30 children including 15 girls and 15 boys were included in each group after intervention and control groups were matched in themselves in terms of gender. The study followed the CONSORT guideline for reporting randomized controlled trials.
- Being tested
- Balloon Blowing, Ball Squeezing, Coughing, Control
- Keywords
- pain management, pain in children, venous blood sample, non-pharmacological method
- Medical subject headings
- Pain, Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Balloon BlowingOther
The parents of the children in this group were asked whether their children had the latex allergy or not and the children without the allergy were included in the group. The children's skills of blowing balloon were observed before the procedure. Before starting the venous blood sampling procedure, the children were asked to choose a balloon in the color they preferred and to start blowing the balloon at least 20 seconds before the procedure. Venous blood sampling started as the children exhaled to blow up the balloon. Until the venous blood procedure ended, they continued to blow up the balloons.
Ball SqueezingOther
Before the venous blood collecting procedure, a soft ball was given to the right hands of the children and they were asked to squeeze and release this ball during the procedure.
CoughingOther
The children included in this group were asked to cough after taking a deep breath during the venous blood sampling procedure. Before the procedure, the researcher showed the children how they should cough and asked them to imitate. The venous blood sampling was not performed until the child successfully completed coughing. The child was directed by the researcher during the procedure. Just before the entrance of the needle, the child was asked to take a deep breath and the venous blood sampling procedure was started during coughing.
ControlOther
No intervention was performed to reduce pain and fear in the control group.
| Study group | Role | What they receive |
|---|---|---|
| Balloon Blowing | Experimental | Venous blood sampling started as the children exhaled to blow up the balloon. Until the venous blood procedure ended, they continued to blow up the balloons. Receives: Other: Balloon Blowing |
| Ball Squeezing | Experimental | Before the venous blood collecting procedure, a soft ball was given to the right hands of the children and they were asked to squeeze and release this ball during the procedure. Receives: Other: Ball Squeezing |
| Coughing | Experimental | Just before the entrance of the needle, the child was asked to take a deep breath and the venous blood sampling procedure was started during coughing. Receives: Other: Coughing |
| Control | Experimental | No intervention was performed to reduce pain and fear in the control group. Receives: Other: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain severity
The children and the parents were informed about the Wong Baker Faces Pain Rating Scale and they were asked to mark the children's pain levels on the scale 5 minutes before and after the venipuncture procedure. In addition, the pain levels of the children before and after the procedure were determined by the researcher who is a specialist in pediatric nursing by using the same scales.
Wong Baker Faces Pain Rating Scale was developed by Donna Wong and Connie Morain Baker in 1981 and revised in 1983. The scale is one of the commonly used scales for measuring pain severity in children aged between 3-18 years. This scale has the faces and the pain score is determined according to the numerical values given to the faces. While smiley face "0 point" shows lack of pain, crying face "10 points" refer to severe pain.
Measured: 5 MONTHS
Secondary outcomes (1)
Fear levels
The children and the parents were informed about the Children's Fear Scale and they were asked to mark the children's fear levels on the scale within 5 mins before and after the venipuncture procedure. In addition, the fear levels of the children before and after the procedure were determined by the researcher who is a specialist in pediatric nursing by using the same scales.
Children's Fear Scales has five facial expression and the fear is scored according to the numerical values given to the faces on the scale. The leftmost face "0 point" in the scale represents that the child has no fear and the rightmost face "4 points" represent that the child is frightened a lot.
Measured: 5 MONTHS
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Oct 2018
- Study start1 Mar 2017
- Primary completion20 Jul 2017
- Study completion15 Nov 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PainStudies of the same condition, open and under way.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Çankırı Karatekin University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, İLKNUR GÖL, Çankırı Karatekin University
- Investigators
- Burcu AYKANAT GİRGİN, PhD.RN, Principal investigator, Saglik Bilimleri Universitesi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03720808
- Sponsor's protocol ID
- SY200217B06
- Status last verified
- Oct 2018
- First submitted
- 24 Oct 2018
- Last updated
- 26 Oct 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Comparison Of The Efficacy Of Three Methods Applied During Venous Blood Sampling On Reducing Pain And Fear In Children
- ClinicalTrials.gov ID
- NCT03720808
- Acronym / sponsor ID
- SY200217B06
- Keywords
- pain management, pain in children, venous blood sample, non-pharmacological method
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Çankırı Karatekin UniversityUniversity, hospital or other
- Study start
- 1 Mar 2017 (actual)
- Primary completion
- 20 Jul 2017 (actual)
- Study completion
- 15 Nov 2017 (actual)
- First posted
- 25 Oct 2018 (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.
This study is an experimental randomized controlled study conducted to compare the effect of balloon blowing, coughing, and ball squeezing methods applied during venous blood sampling from on pain and fear level in 7-12 year-old children. The population of the study consisted of all 7-12 year-old children who were referred to the blood-letting room for venous blood sampling in a state hospital. The sample of the study was determined as 120 children with confidence level of 95% and theoretical power of 95%. The children were divided into 4 groups of 30 people, including balloon blowing, ball squeezing, coughing, and control groups. Each intervention and control group was matched in terms of gender. In the study, the randomization of the sample group was performed by using stratification and block randomization methods.
Detailed description
The study is a randomized controlled, non-blinded, experimental trial. The population of the study consisted of all 7-12 year-old children who came to the venipuncture room in the state hospital.It is stated in the literature that the sample size should be determined as minimum 30 in both experimental and control groups in the experimental studies and parametric measurements. Therefore, in the study, each group included 30 children including three experimental groups and a control group and in the power analysis, power of the study was found as 0.95 at the confidence level of 95%. In order to prevent bias and increase the validity of the data, the pain and fear scores of the children before and after the procedure were assessed by three different groups as children participating in the study (n:120), their parents as the people who know the children best (n:120), and a researcher specialized in pediatric nursing (n:1), and the inter-observer agreement was examined. The level of pain was assessed by the Wong Baker Faces Scale and the fear of pain was assessed by the Children's Fear Scale.
In this experimental study, the children and their parents who came to the venipuncture room for venous blood sampling were evaluated in terms of the inclusion criteria and the children and parents who did not meet the criteria were excluded from the study. The children and parents complying with the inclusion criteria were informed about the study and their written and verbal consents were received. The children were included in one of the 4 study groups, including the balloon blowing, coughing, ball squeezing, and the control group without any intervention. In the studies, it was determined that gender had an important effect on evaluation of pain.39,40 In order to control the effect of gender on pain, the children were stratified into study groups based on their gender and selected by using block randomization method in four study groups. The children were randomized to the related study group by drawing one of the study groups in the cloth bags prepared for the girls (pink) and the boys (blue). Papers with the same color and folding pattern representing the four groups (1,2,3,4) were thrown in the bags. In order to provide a randomized distribution and to reduce all negative effects, the children were asked to take randomly a paper from the bag according to the gender after making the necessary explanation to the parents and their children so that the groups became self-balancing. A total of 30 children including 15 girls and 15 boys were included in each group after intervention and control groups were matched in themselves in terms of gender. The study followed the CONSORT guideline for reporting randomized controlled trials.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Balloon Blowing | Experimental | Other: Balloon BlowingVenous blood sampling started as the children exhaled to blow up the balloon. Until the venous blood procedure ended, they continued to blow up the balloons. |
| Ball Squeezing | Experimental | Other: Ball SqueezingBefore the venous blood collecting procedure, a soft ball was given to the right hands of the children and they were asked to squeeze and release this ball during the procedure. |
| Coughing | Experimental | Other: CoughingJust before the entrance of the needle, the child was asked to take a deep breath and the venous blood sampling procedure was started during coughing. |
| Control | Experimental | Other: ControlNo intervention was performed to reduce pain and fear in the control group. |
Who may qualify
- Ages
- 7 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (11 listed)
- The children,
- who were aged between 7-12 years,
- were healthy,
- did not receive any analgesic within the last 6 hours before venipuncture procedure,
- had no history of syncope during venipuncture procedure,
Key exclusion criteria (7 listed)
- The children;
- who had neuro-developmental disorder,
- could not communicate verbally,
- had hearing and visual impairment,
- suffered from acute pyretic disease,
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 |
|---|---|---|
| Balloon BlowingThe parents of the children in this group were asked whether their children had the latex allergy or not and the children without the allergy were included in the group. The children's skills of blowing balloon were observed before the procedure. Before starting the venous blood sampling procedure, the children were asked to choose a balloon in the color they preferred and to start blowing the balloon at least 20 seconds before the procedure. Venous blood sampling started as the children exhaled to blow up the balloon. Until the venous blood procedure ended, they continued to blow up the balloons. | Other | Balloon Blowing |
| Ball SqueezingBefore the venous blood collecting procedure, a soft ball was given to the right hands of the children and they were asked to squeeze and release this ball during the procedure. | Other | Ball Squeezing |
| CoughingThe children included in this group were asked to cough after taking a deep breath during the venous blood sampling procedure. Before the procedure, the researcher showed the children how they should cough and asked them to imitate. The venous blood sampling was not performed until the child successfully completed coughing. The child was directed by the researcher during the procedure. Just before the entrance of the needle, the child was asked to take a deep breath and the venous blood sampling procedure was started during coughing. | Other | Coughing |
| ControlNo intervention was performed to reduce pain and fear in the control group. | Other | Control |
Primary outcome
Pain severity
Time frame: 5 MONTHS
The children and the parents were informed about the Wong Baker Faces Pain Rating Scale and they were asked to mark the children's pain levels on the scale 5 minutes before and after the venipuncture procedure. In addition, the pain levels of the children before and after the procedure were determined by the researcher who is a specialist in pediatric nursing by using the same scales. Wong Baker Faces Pain Rating Scale was developed by Donna Wong and Connie Morain Baker in 1981 and revised in 1983. The scale is one of the commonly used scales for measuring pain severity in children aged between 3-18 years. This scale has the faces and the pain score is determined according to the numerical values given to the faces. While smiley face "0 point" shows lack of pain, crying face "10 points" refer to severe pain.
1 secondary outcome
Fear levels
Time frame: 5 MONTHS
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 26 Oct 2018.
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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.
Burcu AYKANAT GİRGİN, PhD.RN principal investigator
Saglik Bilimleri Universitesi
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Balloon Blowing, Ball Squeezing and Coughing in people with Pain and Fear, run by Çankırı Karatekin 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 11 inclusion and 7 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 26 Oct 2018. 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?
Pain severity (time frame: 5 MONTHS). 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 26 Oct 2018.