Preterm LaborNCT05430321
The Effect of Facilitated Tucking After Vaginal Delivery on Late Preterm Stress, Comfort and Physiological Parameters
A study testing Assessment of physiological parameters, Assessment of Stress and Assessment of Comfort in people with Preterm Labor and Preterm Labor With Preterm Delivery in Third Trimester, run by Istanbul University - Cerrahpasa at 1 site in Turkey (Türkiye).
Trial summary
Objective: It is aimed to examine the effect of facilitated tucking after vaginal delivery on late preterm stress, comfort and physiological parameters. Design: The study was designed randomized controlled study. Read more about this study
- Who is it for?
- Ages 1 hour to 2 hoursHealthy volunteers can take part
- Conditions the study is for
- Preterm Labor, Preterm Labor With Preterm Delivery in Third Trimester, Preterm Spontaneous Labor With Preterm Delivery
- What is being tested?
- Assessment of physiological parameters, Assessment of Stress and Assessment of Comfort
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jan 2020to 1 Jun 2020
- 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 1 hour to 2 hours
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- spontaneous vaginal delivery,
- Apgar score 1. min > 7
- between 35-36 (6/7) gestation weeks,
- without congenital anomaly or any syndrome,
- surgery is not needed,
- mechanical ventilation is not needed,
- accepted by parents.
Who cannot join
- in addition to the exact opposite of the items identified in the inclusion criteria, also cesarean, neonatal resuscitation is needed, newborn first vaccinations practices excluded.
Trial locations and contacts
1 site in 1 country.
About this study
Objective: It is aimed to examine the effect of facilitated tucking after vaginal delivery on late preterm stress, comfort and physiological parameters.
Design: The study was designed randomized controlled study. Setting: The study was conducted spontaneous vaginal delivery of late preterm at State Hospital between January-June 2020.
Read more
Participants: In order to determine the sample size of the study, power analysis was performed using the G*Power (v3.1, 7) program, and a total of 60 preterm were sampled, facilitated tucking (n=30) and control group (n=30).
Methods: In the study, Newborn Information and Registration Form, Neonatal Comfort Behavior Scale (NCBS) and Newborn Stress Scale (NSS) were used. As for physiological parameters, for the temperature is used private digital thermometer, for the saturation and heart rate is used device preferred in hospital routine and lastly the respirator rate is clocked by nurses.
Read the detailed description
Facilitated tucking (FT) is a procedure that kindly flexes the newborn by placing hands on the head and hips. There is no mentioned any risk about this implementation in the literature review. Its effects are that it improves the sleep quality of the newborn and stabilizes the physiological parameters helps to gain a sense of safety related to the position, support the motor development and protect the energy. Studies have shown that facilitated tucking is practiced many times, especially pain management; however, no study has been found examining how it affects stress and comfort of the preterm newborns first nursing care after delivery. Furthermore, vaginal delivery can be a cause of stress alone for all newborns. During these procedures, nursing practices are needed to relieve the stress and to provide comfort on the newborn. Therefore, it is aimed to examine the effect of facilitated tucking after vaginal delivery on late preterm stress, comfort and physiological parameters.
Material and Method: Power analysis for the present study was based on the study by a study which performed the study with at least 32, 30 preterm in each group (with 95% confidence interval and 5% alpha (two tailed)). Herein, the present study was performed with a total of 60 preterm corresponding to 30 preterm for each experimental group (It was assumed that could be lost cases during the study).Randomization was achieved by means of the computer program (https://www.randomizer.org) indicating the total number of preterm, groups and preterm groups and the preterm divided into control and experimental groups.
Experimental group: In order to eliminate the pain and stress that they experience during routine care after vaginal delivery to late preterm. FT implementation begins 3 minutes before the procedures and 10 minutes continuous. After the end of the procedures further 3 minutes was given. Physiological parameters were simultaneously recorded on the registration form. Neonatal Comfort Behavior Scale (NCBS) and Newborn Stress Scale (NSS) were used end of the all procedures which means 13th minute. While FT was implemented by researcher, postpartum care for newborn was performed and recorded by same nurse who is on shift. Evaluation of the scales was evaluated by the researcher and the nurse working in the hospital shift (with 5 years of neonatal experience) (Observer I-Observer II).
Control group: In this group was implemented of the hospital routine care (supine position). Physiological parameters were simultaneously recorded after the vaginal delivery. Neonatal Comfort Behavior Scale (NCBS) and Newborn Stress Scale (NSS) were used end of the all procedures which means 13th minute. Evaluation of the scales was evaluated by the researcher and the nurse working in the hospital shift (with 5 years of neonatal experience) (Observer I-Observer II).
- Conditions
- Preterm Labor, Preterm Labor With Preterm Delivery in Third Trimester, Preterm Spontaneous Labor With Preterm Delivery
- Being tested
- Assessment of physiological parameters, Assessment of Stress, Assessment of Comfort
- Medical subject headings
- Obstetric Labor, Premature
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Assessment of physiological parametersOther
FT implementation begins 3 minutes before the procedures and 10 minutes continuous. After the end of the procedures further 3 minutes was given . Physiological parameters were simultaneously recorded on the registration form
Assessment of StressOther
Newborn Stress Scale (NSS) was used end of the all procedures which means 13th minute.
Assessment of ComfortOther
Neonatal Comfort Behavior Scale (NCBS) was used end of the all procedures which means 13th minute.
| Study group | Role | What they receive |
|---|---|---|
| Effect of facilitated tucking after preterm labor | Experimental | Implementation of facilitated tucking after preterm labor Receives: Other: Assessment of physiological parameters; Other: Assessment of Stress; Other: Assessment of Comfort |
| Supine position after preterm labor | No intervention | Implementation of supine position after preterm labor |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sample characteristic
the characteristics of the preterm infants and their mothers in the groups.
Measured: 13 minutes
Physiological parameter (Heart rate)-1
the parameters (heart rate) of the groups were compared at hospitalization, 1st, 5th, 10th and 13th minutes.
Measured: 13 minutes
Physiological parameter (oxygen saturation)-2
the parameters (oxygen saturation) of the groups were compared at hospitalization, 1st, 5th, 10th and 13th minutes.
Measured: 13 minutes
Physiological parameter (respiratory rate)-3
It was stated that the parameters (respiratory rate) of the groups.
Measured: 13 minutes
Neonatal Stress Scale scores
It was stated that the mean Neonatal Stress Scale scores between groups (min=3 max=11).
Measured: 13 minutes
Newborn Comfort Behaviour Scale scores
It was determined that the mean Newborn Comfort Behaviour Scale scores between groups (min=6 max 30).
Measured: 13 minutes
Physiological parameter (body temperature)-4
It was observed that the parameters (body temperature).
Measured: 13 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2022
- Study start1 Jan 2020
- Primary completion1 Jun 2020
- Study completion1 Jun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Preterm LaborStudies of the same condition, open and under way.
- More trials run by Istanbul University - CerrahpasaThe 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul University - Cerrahpasa
- Sponsor type
- University, hospital or other
- Collaborators
- Kilis 7 Aralik University
- Responsible party
- Principal investigator, SERAP ÖZDEMİR, Istanbul University - Cerrahpasa
- Investigators
- Feyza Bulbul, PhD, Principal investigator, Pediatric Nursing
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05430321
- Sponsor's protocol ID
- Istanbul
- Status last verified
- Jun 2022
- First submitted
- 4 Oct 2021
- Last updated
- 15 Oct 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Researchers would like to share all manuscript other colleges if this study is published.
Publications
Hartley KA, Miller CS, Gephart SM. Facilitated tucking to reduce pain in neonates: evidence for best practice. Adv Neonatal Care. 2015 Jun;15(3):201-8. doi: 10.1097/ANC.0000000000000193.
PubMed 26002861Apaydin Cirik V, Efe E. The effect of expressed breast milk, swaddling and facilitated tucking methods in reducing the pain caused by orogastric tube insertion in preterm infants: A randomized controlled trial. Int J Nurs Stud. 2020 Apr;104:103532. doi: 10.1016/j.ijnurstu.2020.103532. Epub 2020 Jan 24.
PubMed 32062050Cignacco E, Axelin A, Stoffel L, Sellam G, Anand K, Engberg S. Facilitated tucking as a non-pharmacological intervention for neonatal pain relief: is it clinically feasible? Acta Paediatr. 2010 Dec;99(12):1763-5. doi: 10.1111/j.1651-2227.2010.01941.x.
PubMed 20618166Davari S, Borimnejad L, Khosravi S, Haghani H. The effect of the facilitated tucking position on pain intensity during heel stick blood sampling in premature infants: a surprising result. J Matern Fetal Neonatal Med. 2019 Oct;32(20):3427-3430. doi: 10.1080/14767058.2018.1465550. Epub 2018 Apr 26.
PubMed 29656669Gautheyrou L, Durand S, Jourdes E, De Jonckheere J, Combes C, Cambonie G. Facilitated tucking during early neonatologist-performed echocardiography in very preterm neonates. Acta Paediatr. 2018 Dec;107(12):2079-2085. doi: 10.1111/apa.14555. Epub 2018 Sep 21.
PubMed 30144169
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Facilitated Tucking After Vaginal Delivery on Late Preterm Stress, Comfort and Physiological Parameters
- ClinicalTrials.gov ID
- NCT05430321
- Acronym / sponsor ID
- Istanbul
- Conditions
- Preterm Labor, Preterm Labor With Preterm Delivery in Third Trimester, Preterm Spontaneous Labor With Preterm Delivery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Istanbul University - CerrahpasaUniversity, hospital or other
- Collaborators
- Kilis 7 Aralik University
- Study start
- 1 Jan 2020 (actual)
- Primary completion
- 1 Jun 2020 (actual)
- Study completion
- 1 Jun 2020 (actual)
- First posted
- 24 Jun 2022 (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.
Objective: It is aimed to examine the effect of facilitated tucking after vaginal delivery on late preterm stress, comfort and physiological parameters.
Design: The study was designed randomized controlled study. Setting: The study was conducted spontaneous vaginal delivery of late preterm at State Hospital between January-June 2020.
Participants: In order to determine the sample size of the study, power analysis was performed using the G*Power (v3.1, 7) program, and a total of 60 preterm were sampled, facilitated tucking (n=30) and control group (n=30).
Methods: In the study, Newborn Information and Registration Form, Neonatal Comfort Behavior Scale (NCBS) and Newborn Stress Scale (NSS) were used. As for physiological parameters, for the temperature is used private digital thermometer, for the saturation and heart rate is used device preferred in hospital routine and lastly the respirator rate is clocked by nurses.
Detailed description
Facilitated tucking (FT) is a procedure that kindly flexes the newborn by placing hands on the head and hips. There is no mentioned any risk about this implementation in the literature review. Its effects are that it improves the sleep quality of the newborn and stabilizes the physiological parameters helps to gain a sense of safety related to the position, support the motor development and protect the energy. Studies have shown that facilitated tucking is practiced many times, especially pain management; however, no study has been found examining how it affects stress and comfort of the preterm newborns first nursing care after delivery. Furthermore, vaginal delivery can be a cause of stress alone for all newborns. During these procedures, nursing practices are needed to relieve the stress and to provide comfort on the newborn. Therefore, it is aimed to examine the effect of facilitated tucking after vaginal delivery on late preterm stress, comfort and physiological parameters.
Material and Method: Power analysis for the present study was based on the study by a study which performed the study with at least 32, 30 preterm in each group (with 95% confidence interval and 5% alpha (two tailed)). Herein, the present study was performed with a total of 60 preterm corresponding to 30 preterm for each experimental group (It was assumed that could be lost cases during the study).Randomization was achieved by means of the computer program (https://www.randomizer.org) indicating the total number of preterm, groups and preterm groups and the preterm divided into control and experimental groups.
Experimental group: In order to eliminate the pain and stress that they experience during routine care after vaginal delivery to late preterm. FT implementation begins 3 minutes before the procedures and 10 minutes continuous. After the end of the procedures further 3 minutes was given. Physiological parameters were simultaneously recorded on the registration form. Neonatal Comfort Behavior Scale (NCBS) and Newborn Stress Scale (NSS) were used end of the all procedures which means 13th minute. While FT was implemented by researcher, postpartum care for newborn was performed and recorded by same nurse who is on shift. Evaluation of the scales was evaluated by the researcher and the nurse working in the hospital shift (with 5 years of neonatal experience) (Observer I-Observer II).
Control group: In this group was implemented of the hospital routine care (supine position). Physiological parameters were simultaneously recorded after the vaginal delivery. Neonatal Comfort Behavior Scale (NCBS) and Newborn Stress Scale (NSS) were used end of the all procedures which means 13th minute. Evaluation of the scales was evaluated by the researcher and the nurse working in the hospital shift (with 5 years of neonatal experience) (Observer I-Observer II).
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Effect of facilitated tucking after preterm labor | Experimental | Other: Assessment of physiological parameters, Other: Assessment of Stress, Other: Assessment of ComfortImplementation of facilitated tucking after preterm labor |
| Supine position after preterm labor | No intervention | –Implementation of supine position after preterm labor |
Who may qualify
- Ages
- 1 hour to 2 hours
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- spontaneous vaginal delivery,
- Apgar score 1. min > 7
- between 35-36 (6/7) gestation weeks,
- without congenital anomaly or any syndrome,
- surgery is not needed,
Key exclusion criteria (1 listed)
- in addition to the exact opposite of the items identified in the inclusion criteria, also cesarean, neonatal resuscitation is needed, newborn first vaccinations practices excluded.
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 |
|---|---|---|
| Assessment of physiological parametersFT implementation begins 3 minutes before the procedures and 10 minutes continuous. After the end of the procedures further 3 minutes was given . Physiological parameters were simultaneously recorded on the registration form | Other | Effect of facilitated tucking after preterm labor |
| Assessment of StressNewborn Stress Scale (NSS) was used end of the all procedures which means 13th minute. | Other | Effect of facilitated tucking after preterm labor |
| Assessment of ComfortNeonatal Comfort Behavior Scale (NCBS) was used end of the all procedures which means 13th minute. | Other | Effect of facilitated tucking after preterm labor |
Primary outcome
Sample characteristic
Time frame: 13 minutes
the characteristics of the preterm infants and their mothers in the groups.
Physiological parameter (Heart rate)-1
Time frame: 13 minutes
the parameters (heart rate) of the groups were compared at hospitalization, 1st, 5th, 10th and 13th minutes.
Physiological parameter (oxygen saturation)-2
Time frame: 13 minutes
the parameters (oxygen saturation) of the groups were compared at hospitalization, 1st, 5th, 10th and 13th minutes.
Physiological parameter (respiratory rate)-3
Time frame: 13 minutes
It was stated that the parameters (respiratory rate) of the groups.
Neonatal Stress Scale scores
Time frame: 13 minutes
It was stated that the mean Neonatal Stress Scale scores between groups (min=3 max=11).
Newborn Comfort Behaviour Scale scores
Time frame: 13 minutes
It was determined that the mean Newborn Comfort Behaviour Scale scores between groups (min=6 max 30).
Physiological parameter (body temperature)-4
Time frame: 13 minutes
It was observed that the parameters (body temperature).
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 15 Oct 2024.
- Results publication: PubMed 26002861Hartley KA, Miller CS, Gephart SM. Facilitated tucking to reduce pain in neonates: evidence for best practice. Adv Neonatal Care. 2015 Jun;15(3):201-8. doi: 10.1097/ANC.0000000000000193.
- Results publication: PubMed 32062050Apaydin Cirik V, Efe E. The effect of expressed breast milk, swaddling and facilitated tucking methods in reducing the pain caused by orogastric tube insertion in preterm infants: A randomized controlled trial. Int J Nurs Stud. 2020 Apr;104:103532. doi: 10.1016/j.ijnurstu.2020.103532. Epub 2020 Jan 24.
- Results publication: PubMed 20618166Cignacco E, Axelin A, Stoffel L, Sellam G, Anand K, Engberg S. Facilitated tucking as a non-pharmacological intervention for neonatal pain relief: is it clinically feasible? Acta Paediatr. 2010 Dec;99(12):1763-5. doi: 10.1111/j.1651-2227.2010.01941.x.
- Results publication: PubMed 29656669Davari S, Borimnejad L, Khosravi S, Haghani H. The effect of the facilitated tucking position on pain intensity during heel stick blood sampling in premature infants: a surprising result. J Matern Fetal Neonatal Med. 2019 Oct;32(20):3427-3430. doi: 10.1080/14767058.2018.1465550. Epub 2018 Apr 26.
- Results publication: PubMed 30144169Gautheyrou L, Durand S, Jourdes E, De Jonckheere J, Combes C, Cambonie G. Facilitated tucking during early neonatologist-performed echocardiography in very preterm neonates. Acta Paediatr. 2018 Dec;107(12):2079-2085. doi: 10.1111/apa.14555. Epub 2018 Sep 21.
- Individual participant dataSharing planned: Yes. Researchers would like to share all manuscript other colleges if this study is published.
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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.
Feyza Bulbul, PhD principal investigator
Pediatric 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 Assessment of physiological parameters, Assessment of Stress and Assessment of Comfort in people with Preterm Labor and Preterm Labor With Preterm Delivery in Third Trimester, run by Istanbul University - Cerrahpasa 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 7 inclusion and 1 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 15 Oct 2024. 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?
Sample characteristic (time frame: 13 minutes). The study lists 7 primary outcomes in all. 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 NCT05430321, which also lists 5 linked publications.
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 15 Oct 2024.