PainNCT05173662
The Effect of Pain Management Education on The Mothers in Newborn
A study testing Providing education and brochures on non-pharmacological methods that can be applied during the heel blood collection process in people with Pain and Procedural Pain, run by Selcuk University at 2 sites in Turkey (Türkiye).
Trial summary
The aim of this study was to determine the effect of non-pharmacological pain management education given to mothers on the use of non-pharmacological methods and anxiety levels of mothers during routine heel blood collection (guthrie screening test) in term newborns. Read more about this study
- Who is it for?
- Ages 38 to 42 weeksHealthy volunteers can take part
- Conditions the study is for
- Pain, Procedural Pain, Infant ALL
- What is being tested?
- Providing education and brochures on non-pharmacological methods that can be applied during the heel blood collection process
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 2 sitesTurkey (Türkiye)
- Study dates
- 10 Jul 2021to 24 Nov 2021
- 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 38 to 42 weeks
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- For newborns;
- Being a healthy term newborn (born at 38-42 weeks of gestation)
- A blood sample will be taken for the Guthrie screening test.
- Having the mother with the baby (Gynecology and Obstetrics Clinic) for mothers;
- Volunteering to participate in the study
- Ability to read and write Turkish
- Being over 18 years old
Who cannot join
- For newborns;
- Having a congenital anomaly
- Having received any analgesia before the procedure
- IInability to draw blood in one go for mothers;
- Rejection of heel blood collection voluntarily
- Existence of any obstacle that may make communication difficult
Trial locations and contacts
2 sites in 1 country.
Turkey (Türkiye)2 sites
Selcuk University
Konya, Selcuklu, 42060
Selcuk University
Konya
About this study
Official title: The Effect of Pain Management Education on The Mothers on The Use of Nonpharmacological Practices and Anxiety Level in Heel Stick in Newborn
The aim of this study was to determine the effect of non-pharmacological pain management education given to mothers on the use of non-pharmacological methods and anxiety levels of mothers during routine heel blood collection (guthrie screening test) in term newborns.
H0= There was no difference between the intervention group who received non-pharmacological pain management education and the control group's level of anxiety and use of non-pharmacological applications.
Read more
H1= The use of non-pharmacological methods is different between the intervention group and the control group that received non-pharmacological pain management education.
H2= Anxiety scores of the intervention group that received non-pharmacological pain management education and the control group were different.
H3= Some characteristics and anxiety levels of mothers have an effect on their use of non-pharmacological methods.
It was carried out between July - September 2021 at the Akşehir State Hospital Gynecology and Obstetrics Clinic, which serves in the Akşehir district of Konya province.
Read the detailed description
In this study was to determine the effect of pain management education on mothers' use of non-pharmacological methods and anxiety levels during newborn heel blood screening.
This study was designed as parallel group, pre-test and post-test randomized controlled trial.
Based on 80% power and 95% confidence level, the sample size was calculated as 32 infants for each group, a total of 64 infants (G*Power 3.1.9.2).
Randomization In this study, stratified randomization method was applied. Eight blocks of four were created with the permutation-blocked randomization method.
With the computer program (randomized.org), the numbers from 1 to 6 were listed 8 times (6,3,5,2,2,6,6,5) and the combinations were sorted according to this group, and assignments were made to the intervention and control groups.
Blinding The researcher and participant (mothers) could not be blinded since the researcher had to provide training and manage the process before the application. In order to avoid bias in the evaluation of the data, the analysis of the coded data in terms of groups was done by an independent statistician. After the statistical analyzes were completed and the research report was written, the researcher explained the coding of the intervention and control groups. In this way, single blindness was achieved.
In the collection of research data; Introductory Information Form, Non-pharmacological Method Application Checklist and Spielberger State Anxiety Inventory were used. In addition, the mothers in the intervention group were given a brochure on Nonpharmacological Pain Management Education Nonpharmacological Pain Management Education Brochure
This brochure was prepared by the researcher in line with the literature .The brochure contains methods for non-pharmacological pain management that can be applied during procedural painful interventions in newborns. These methods are; expressed breast milk, hugging, skin-to-skin contact, cuddling, calming sounds. The brochure contains information and drawings about the methods. The drawings were created by Architect Merve Özkald. Opinions were received from five experts in terms of the content, language, design and visual suitability of the brochure and the Content Validity Index (CGI) was calculated as 0.890.
Data collection Voluntary Informing Consent Form was obtained from the mothers before the study, and the Introductory Information Form was collected from the mothers by the researcher by face-to-face interview method. Between the dates of the study, mothers of newborns who met the inclusion criteria were randomly assigned to intervention and control groups. Heel blood collection in all newborns; The study was carried out between the 24th and 48th hours of the baby's life, in the gynecology and obstetrics clinic, only in the room where the mother and baby stay together, without any intervention to the baby, by removing the clothes from the lower part of the baby in its natural position.
The heel blood collection procedure was applied in such a way that the baby was next to the mother. No non-pharmacological method was used in routine practice during the procedure.
In this study; The heel blood collection procedure was performed by the same nurse working in the NICU for each infant at one time and by taking the same amount of blood from each infant on average.
At least half an hour before the heel blood collection, it was ensured that the babies were fed and their diapers were clean. During the blood collection process; Standardization of the blood collection technique used, the area where the blood was taken (outer side of the right heel), the needle used in the procedure (needle number 21), environmental factors (such as heat, light, noise), used antiseptic solution (70% alcohol) provided.
To the mothers in the intervention group; At least 12 hours before the heel blood collection (guthrie screening test), information was given by the researcher (FU) about the purpose of the heel blood collection procedure and the application process, and the questions, if any, were answered. Afterwards, an average of 25 minutes of education was given through the training brochure prepared by the researcher on non-pharmacological pain management. The education was carried out in a language that the mother could understand, in the form of direct lectures and questions and answers, using the visuals in the brochure.
The mothers in the control group, on the other hand, were informed by the researcher about the purpose of the heel blood collection procedure and the application process at least 12 hours before the guthrie screening test, and their questions were answered, if any, and no other application was made.
- Conditions
- Pain, Procedural Pain, Infant ALL
- Being tested
- Providing education and brochures on non-pharmacological methods that can be applied during the heel blood collection process
- Keywords
- pain, procedural, newborn, heel blood collection procedure, Education on nonpharmacological methods
- Medical subject headings
- Pain, Pain, Procedural
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Providing education and brochures on non-pharmacological methods that can be applied during the heel blood collection processProcedure or surgery
Theeduvation initiative was implemented by the researcher at least 12 hours ago in the mothers' room and a brochure was given about the education.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group | Experimental | To the mothers in this group; At least 12 hours before the heel blood collection (guthrie screening test), training was given, lasting 25 minutes, on average, through the training brochure on non-pharmacological pain management prepared by the researcher. The training was carried out in a language that the mother could understand, in the form of direct lectures and questions and answers, using the visuals in the brochure. In the training content; There are five non-pharmacological methods. These;
* Expressed breast milk
* Wrapping
* Skin-to-skin contact
* Cuddling
* They are methods of making calming sounds. Receives: Procedure: Providing education and brochures on non-pharmacological methods that can be applied during the heel blood collection process |
| Control Group | No intervention | In the control group, as in the clinical routine, the heel stick procedure was performed in the newborn's own bed next to his mother. No other action has been applied. |
What is being measured
The primary outcome is the main question the study is designed to answer.
The mothers' use of non-pharmacological methods
The mothers' use of non-pharmacological methods during heel blood collection. These methods are; expressed breast milk, hugging, skin-to-skin contact, cuddling, calming sounds. The cases of using the methods were determined as yes and no for each method.
Measured: After the process first 10 minute
Secondary outcomes (1)
State anxiety level scores of mothers
The State and Trait Anxiety Inventory (STAI) was developed by Spielberger in 1983.
The STAI consists of two subscales of 20 questions about state and trait anxiety.
All questions are in a four-point Likert type. The scores of both subscales are summed separately and a total score between 20 and 80 is obtained.
Higher scores indicate a higher level of anxiety.
Measured: Pre-test 5-10 minutes before the process and 10 minutes after the process
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Dec 2021
- Study start10 Jul 2021
- Primary completion24 Sep 2021
- Study completion24 Nov 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for PainStudies of the same condition, open and under way.
- More trials run by Selcuk 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
- Model description
- Intervention Group Education was given about non-pharmacological methods that can be applied during the heel blood collection procedure in newborns and a brochure was given. Control group: no intervention was made.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- Selcuk University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fatma Taş Arslan, Selcuk University
- Investigators
- Fulya Unvar, Study chair, Konya Aksehir State Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05173662
- Sponsor's protocol ID
- SelcukU-11-2021
- Status last verified
- Dec 2021
- First submitted
- 29 Nov 2021
- Last updated
- 30 Dec 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Unvar F, Tas Arslan F. Effectiveness of maternal-targeted training on nonpharmacologic pain management on heel stick sampling: A randomized controlled trial. J Pediatr Nurs. 2023 Nov-Dec;73:e477-e483. doi: 10.1016/j.pedn.2023.10.018. Epub 2023 Nov 3.
PubMed 37923615
Study at a glance
From the registry record, last updated by the sponsor on 30 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Pain Management Education on The Mothers on The Use of Nonpharmacological Practices and Anxiety Level in Heel Stick in Newborn
- ClinicalTrials.gov ID
- NCT05173662
- Acronym / sponsor ID
- SelcukU-11-2021
- Conditions
- Pain, Procedural Pain, Infant ALL
- Keywords
- pain, procedural, newborn, heel blood collection procedure, Education on nonpharmacological methods
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- Selcuk UniversityUniversity, hospital or other
- Study start
- 10 Jul 2021 (actual)
- Primary completion
- 24 Sep 2021 (actual)
- Study completion
- 24 Nov 2021 (actual)
- First posted
- 30 Dec 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 aim of this study was to determine the effect of non-pharmacological pain management education given to mothers on the use of non-pharmacological methods and anxiety levels of mothers during routine heel blood collection (guthrie screening test) in term newborns.
H0= There was no difference between the intervention group who received non-pharmacological pain management education and the control group's level of anxiety and use of non-pharmacological applications.
H1= The use of non-pharmacological methods is different between the intervention group and the control group that received non-pharmacological pain management education.
H2= Anxiety scores of the intervention group that received non-pharmacological pain management education and the control group were different.
H3= Some characteristics and anxiety levels of mothers have an effect on their use of non-pharmacological methods.
It was carried out between July - September 2021 at the Akşehir State Hospital Gynecology and Obstetrics Clinic, which serves in the Akşehir district of Konya province.
Detailed description
In this study was to determine the effect of pain management education on mothers' use of non-pharmacological methods and anxiety levels during newborn heel blood screening.
This study was designed as parallel group, pre-test and post-test randomized controlled trial.
Based on 80% power and 95% confidence level, the sample size was calculated as 32 infants for each group, a total of 64 infants (G*Power 3.1.9.2).
Randomization In this study, stratified randomization method was applied. Eight blocks of four were created with the permutation-blocked randomization method.
With the computer program (randomized.org), the numbers from 1 to 6 were listed 8 times (6,3,5,2,2,6,6,5) and the combinations were sorted according to this group, and assignments were made to the intervention and control groups.
Blinding The researcher and participant (mothers) could not be blinded since the researcher had to provide training and manage the process before the application. In order to avoid bias in the evaluation of the data, the analysis of the coded data in terms of groups was done by an independent statistician. After the statistical analyzes were completed and the research report was written, the researcher explained the coding of the intervention and control groups. In this way, single blindness was achieved.
In the collection of research data; Introductory Information Form, Non-pharmacological Method Application Checklist and Spielberger State Anxiety Inventory were used. In addition, the mothers in the intervention group were given a brochure on Nonpharmacological Pain Management Education Nonpharmacological Pain Management Education Brochure
This brochure was prepared by the researcher in line with the literature .The brochure contains methods for non-pharmacological pain management that can be applied during procedural painful interventions in newborns. These methods are; expressed breast milk, hugging, skin-to-skin contact, cuddling, calming sounds. The brochure contains information and drawings about the methods. The drawings were created by Architect Merve Özkald. Opinions were received from five experts in terms of the content, language, design and visual suitability of the brochure and the Content Validity Index (CGI) was calculated as 0.890.
Data collection Voluntary Informing Consent Form was obtained from the mothers before the study, and the Introductory Information Form was collected from the mothers by the researcher by face-to-face interview method. Between the dates of the study, mothers of newborns who met the inclusion criteria were randomly assigned to intervention and control groups. Heel blood collection in all newborns; The study was carried out between the 24th and 48th hours of the baby's life, in the gynecology and obstetrics clinic, only in the room where the mother and baby stay together, without any intervention to the baby, by removing the clothes from the lower part of the baby in its natural position.
The heel blood collection procedure was applied in such a way that the baby was next to the mother. No non-pharmacological method was used in routine practice during the procedure.
In this study; The heel blood collection procedure was performed by the same nurse working in the NICU for each infant at one time and by taking the same amount of blood from each infant on average.
At least half an hour before the heel blood collection, it was ensured that the babies were fed and their diapers were clean. During the blood collection process; Standardization of the blood collection technique used, the area where the blood was taken (outer side of the right heel), the needle used in the procedure (needle number 21), environmental factors (such as heat, light, noise), used antiseptic solution (70% alcohol) provided.
To the mothers in the intervention group; At least 12 hours before the heel blood collection (guthrie screening test), information was given by the researcher (FU) about the purpose of the heel blood collection procedure and the application process, and the questions, if any, were answered. Afterwards, an average of 25 minutes of education was given through the training brochure prepared by the researcher on non-pharmacological pain management. The education was carried out in a language that the mother could understand, in the form of direct lectures and questions and answers, using the visuals in the brochure.
The mothers in the control group, on the other hand, were informed by the researcher about the purpose of the heel blood collection procedure and the application process at least 12 hours before the guthrie screening test, and their questions were answered, if any, and no other application was made.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Intervention Group Education was given about non-pharmacological methods that can be applied during the heel blood collection procedure in newborns and a brochure was given. Control group: no intervention was made.
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Experimental | Procedure: Providing education and brochures on non-pharmacological methods that can be applied during the heel blood collection processTo the mothers in this group; At least 12 hours before the heel blood collection (guthrie screening test), training was given, lasting 25 minutes, on average, through the training brochure on non-pharmacological pain management prepared by the researcher. The training was carried out in a language that the mother could understand, in the form of direct lectures and questions and answers, using the visuals in the brochure. In the training content; There are five non-pharmacological methods. These; * Expressed breast milk * Wrapping * Skin-to-skin contact * Cuddling * They are methods of making calming sounds. |
| Control Group | No intervention | –In the control group, as in the clinical routine, the heel stick procedure was performed in the newborn's own bed next to his mother. No other action has been applied. |
Who may qualify
- Ages
- 38 to 42 weeks
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- For newborns;
- Being a healthy term newborn (born at 38-42 weeks of gestation)
- A blood sample will be taken for the Guthrie screening test.
- Having the mother with the baby (Gynecology and Obstetrics Clinic) for mothers;
- Volunteering to participate in the study
Key exclusion criteria (6 listed)
- For newborns;
- Having a congenital anomaly
- Having received any analgesia before the procedure
- IInability to draw blood in one go for mothers;
- Rejection of heel blood collection voluntarily
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 |
|---|---|---|
| Providing education and brochures on non-pharmacological methods that can be applied during the heel blood collection processTheeduvation initiative was implemented by the researcher at least 12 hours ago in the mothers' room and a brochure was given about the education. | Procedure or surgery | Intervention Group |
Primary outcome
The mothers' use of non-pharmacological methods
Time frame: After the process first 10 minute
The mothers' use of non-pharmacological methods during heel blood collection. These methods are; expressed breast milk, hugging, skin-to-skin contact, cuddling, calming sounds. The cases of using the methods were determined as yes and no for each method.
1 secondary outcome
State anxiety level scores of mothers
Time frame: Pre-test 5-10 minutes before the process and 10 minutes after the process
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 30 Dec 2021.
- Derived from this study: PubMed 37923615Unvar F, Tas Arslan F. Effectiveness of maternal-targeted training on nonpharmacologic pain management on heel stick sampling: A randomized controlled trial. J Pediatr Nurs. 2023 Nov-Dec;73:e477-e483. doi: 10.1016/j.pedn.2023.10.018. Epub 2023 Nov 3.
Related trials for Pain
Not yet recruiting
Effect of Stress Ball Use During Femoral Arterial Sheath Removal After Coronary Angiography
Femoral Arterial Sheath Removal, Stress Ball
Recruiting
Empowered Relief® for Cancer Survivors With Chronic Pain
Chronic Pain Due to Cancer, Pain Catastrophizing
RecruitingPhase 4
ESP Blocks for Posterior Spinal Fusion
Postoperative Pain
RecruitingObservational study
Pain Phenotypes in Individuals With Multiple Sclerosis
Multiple Sclerosis, Chronic Pain
Not yet recruiting
Effects of Hip Hinge Exercises on Pain, Range of Motion and Functional Disability in Non-specific Low Back Pain.
Low Back Pain
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.
Fulya Unvar study chair
Konya Aksehir State Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Providing education and brochures on non-pharmacological methods that can be applied during the heel blood collection process in people with Pain and Procedural Pain, run by Selcuk University at 2 sites 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 7 inclusion and 6 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 30 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
The mothers' use of non-pharmacological methods (time frame: After the process first 10 minute). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05173662, which also lists 1 linked publication.
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 30 Dec 2021.