Preterm InfantsCPAPNCT05577793
Effect of Therapeutic Touch and Mother's Voice on Pain and Comfort Level During Nasal CPAP Application
A study testing Mother's Voice, Therapeutic Touch and Mother's Voice +Therapeutic Touch in people with Preterm Infants and Nasal Continuous Positive Airway Pressure, run by Ayşe Belpınar at 1 site in Turkey (Türkiye).
Trial summary
Aim: This study was conducted to evaluate the effects of Therapeutic Touch and Mother's Voice on pain and comfort levels of preterm infants during nasal CPAP application. Read more about this study
- Who is it for?
- Ages 28 to 37 weeksHealthy volunteers can take part
- Conditions the study is for
- Preterm Infants, Nasal Continuous Positive Airway Pressure, Pain Management
- What is being tested?
- Mother's Voice, Therapeutic Touch and Mother's Voice +Therapeutic Touch
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 124 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Apr 2019to 14 Aug 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 28 to 37 weeks
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- being checked in at Neonatal Intensive Care Unit
- being in the gestational ages of 28 to 37 weeks
- having nasal CPAP
Who cannot join
- having neurological disorders
- having comorbidity
- receiving sedation or analgesics
- having congenital anomaly
- receiving extra invasive procedures or surgical intervention
- being diagnosed with hearing loss
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Cengiz Gökçek Gynecology, Obstetrics and Pediatrics Hospital
Gaziantep, 27060
About this study
Official title: Effect of Therapeutic Touch and Mother's Voice on Pain and Comfort Level During Nasal CPAP Application in Turkey: A Randomized Controlled Study
Aim: This study was conducted to evaluate the effects of Therapeutic Touch and Mother's Voice on pain and comfort levels of preterm infants during nasal CPAP application.
Read the detailed description
Aim: This study was conducted to evaluate the effects of Therapeutic Touch and Mother's Voice on pain and comfort levels of preterm infants during nasal CPAP application.
Design and Method: The study, which used a randomized controlled trial, included 124 preterm neonatal infants a gestational age of 28- 37 weeks and received nasal CPAP. The infants were treated with Mother's Voice, Therapeutic Touch, and Mother's Voice+ Therapeutic Touch. The Neonatal Infant Pain Scale (NIPS) and Premature Infant Comfort Scale (PICS) scores of the infants were measured before, during and after the nasal CPAP application.
- Being tested
- Mother's Voice, Therapeutic Touch, Mother's Voice +Therapeutic Touch, Control
- Keywords
- Nasal continuous positive airway pressure (NCPAP), Therapeutic Touch, Mother's Voice, Pain, Comfort
- Medical subject headings
- Agnosia, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mother's VoiceOther
Also called Mother's Voice Group
The audio recording was made to listen to the baby for 15 minutes during the nasal CPAP application. The NIPS and PICS scores were evaluated and recorded before, during and after the application.
Therapeutic TouchOther
Also called Therapeutic Touch Group
Therapeutic touch was started 5 minutes before nasal prongs were placed, and was applied for 5 minutes during the application, and continued for another 5 minutes after the nasal prongs were placed. The method was applied for a total of 15 minutes as 5 minutes of hand resting, 5 minutes of gentle caressing and 5 more minutes of hand resting.The NIPS and PICS scores were evaluated and recorded before, during and after the application.
Mother's Voice +Therapeutic TouchOther
Also called Mother's Voice +Therapeutic Touch Group
Both applications were applied together for 15 minutes.The NIPS and PICS scores were evaluated and recorded before, during and after the application.
ControlOther
Also called Control Group
The premature babies in the control group did not receive any intervention other than the hospital procedure.The NIPS and PICS scores were evaluated and recorded before, during and after the application.
| Study group | Role | What they receive |
|---|---|---|
| Mother's Voice | Experimental | The mothers were asked to sing lullabies, and their voices were recorded in a quiet environment. Which lullaby they would sing was left to the mothers' discretion, and the audio recording process took an average of 2-3 minutes. The voice recordings taken were applied for a total of 15 minutes before, during and after the nasal CPAP application.The NIPS and PICS scores were evaluated and recorded before, during and after the application. Receives: Other: Therapeutic Touch; Other: Mother's Voice +Therapeutic Touch; Other: Control |
| Therapeutic Touch | Experimental | Therapeutic touch was started 5 minutes before nasal prongs were placed, and was applied for 5 minutes during the application, and continued for another 5 minutes after the nasal prongs were placed. The method was applied for a total of 15 minutes as 5 minutes of hand resting, 5 minutes of gentle caressing and 5 more minutes of hand resting.The NIPS and PICS scores were evaluated and recorded before, during and after the application. Receives: Other: Mother's Voice; Other: Mother's Voice +Therapeutic Touch; Other: Control |
| Mother's Voice+Therapeutic Touch | Experimental | Both applications were applied together for 15 minutes.The NIPS and PICS scores were evaluated and recorded before, during and after the application. Receives: Other: Mother's Voice; Other: Therapeutic Touch; Other: Control |
| Control | No intervention | The premature babies in the control group did not receive any intervention other than the hospital procedure.The NIPS and PICS scores were evaluated and recorded before, during and after the application. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Neonatal Infant Pain Scale (NIPS)
Neonatal Infant Pain Scale (NIPS) was developed by Lawrence et. al. in 1993 in order to assess intervention-related pain in term and preterm babies (Lawrence et al., 1993). The Turkish validity and reliability of the study was conducted in 1999 by Akdovan (Akdovan, 1999). NIPS has six sections on facial expression, crying, respiration state, movements of extremity, and being awake. All behavioral responses except for crying were given two separate scores (0-1 score). Three separate scores were assigned (0-1-2) to crying. The total scores were between 0-7. A high score showed that pain was more intense (Yilmaz \& Arikan, 2011). The Cronbach's a coefficients before, during, and after the intervention were found to be 0.95, 0.87, and 0.88, respectively, by Lawrence et al. (Lawrence et al., 1993).The Neonatal Infant Pain Scale (NIPS) score was evaluated and recorded before, during and 15 minutes after the application.
Measured: 15 minutes
Premature Infant Comfort Scale (PICS)
Premature Infant Comfort Scale (PICS) which was developed by Ambuel et. al. (Ambuel et al., 1992) in order to the measure pain and stress levels of 0-18-month-old children, was later adapted to 28-37-week-old premature infants by Monique et. al. in 2007 (Caljouw et al., 2007) The Premature Infant Comfort Scale assesses 7 parameters such as Awareness, Tranquility/Agitation, Respiration State (only supported by mechanical ventilation) or Crying (it was not assessed because it was scored only in children with spontaneous respiration), Physical Movement, Muscular Tonus, Facial Expressions and Average Cardiac Beat. The scale is 5-point Likert type. As the scale score increases, the comfort level decreases. The scores are between 35 and 7. Comfort decreases as it approaches 35 points, and increases as it approaches 7 points. (Küçük Alemdar \& Güdücü Tüfekci, 2015).Premature Infant Comfort Scale (PICS) score was evaluated and recorded before, during and 15 minutes after the application.
Measured: 15 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Oct 2022
- Study start15 Apr 2019
- Primary completion15 Oct 2019
- Study completion14 Aug 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Preterm InfantsStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This study used a randomized controlled trial. A parallel trial design was used describing three different experimental groups (Therapeutic Touch, Mother's Voice, and Therapeutic Touch+Mother's Voice) and a control group.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 124 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ayşe Belpınar
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Ayşe Belpınar, Bozok University
- Investigators
- Ayşe Belpınar, Msc, Principal investigator, Bozok UniversityEmriye Hilal Yayan, Phd, Principal investigator, Inonu University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05577793
- Sponsor's protocol ID
- ABelpinar
- Acronym
- CPAP
- Status last verified
- Oct 2022
- First submitted
- 23 Sep 2022
- Last updated
- 13 Oct 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Therapeutic Touch and Mother's Voice on Pain and Comfort Level During Nasal CPAP Application in Turkey: A Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT05577793
- Acronym / sponsor ID
- CPAP / ABelpinar
- Keywords
- Nasal continuous positive airway pressure (NCPAP), Therapeutic Touch, Mother's Voice, Pain, Comfort
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 124 participants (actual)
- Lead sponsor
- Ayşe BelpınarUniversity, hospital or other
- Study start
- 15 Apr 2019 (actual)
- Primary completion
- 15 Oct 2019 (actual)
- Study completion
- 14 Aug 2020 (actual)
- First posted
- 13 Oct 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.
Aim: This study was conducted to evaluate the effects of Therapeutic Touch and Mother's Voice on pain and comfort levels of preterm infants during nasal CPAP application.
Detailed description
Aim: This study was conducted to evaluate the effects of Therapeutic Touch and Mother's Voice on pain and comfort levels of preterm infants during nasal CPAP application.
Design and Method: The study, which used a randomized controlled trial, included 124 preterm neonatal infants a gestational age of 28- 37 weeks and received nasal CPAP. The infants were treated with Mother's Voice, Therapeutic Touch, and Mother's Voice+ Therapeutic Touch. The Neonatal Infant Pain Scale (NIPS) and Premature Infant Comfort Scale (PICS) scores of the infants were measured before, during and after the nasal CPAP application.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 4
- Model description
- This study used a randomized controlled trial. A parallel trial design was used describing three different experimental groups (Therapeutic Touch, Mother's Voice, and Therapeutic Touch+Mother's Voice) and a control group.
| Arm | Type | Receives |
|---|---|---|
| Mother's Voice | Experimental | Other: Therapeutic Touch, Other: Mother's Voice +Therapeutic Touch, Other: ControlThe mothers were asked to sing lullabies, and their voices were recorded in a quiet environment. Which lullaby they would sing was left to the mothers' discretion, and the audio recording process took an average of 2-3 minutes. The voice recordings taken were applied for a total of 15 minutes before, during and after the nasal CPAP application.The NIPS and PICS scores were evaluated and recorded before, during and after the application. |
| Therapeutic Touch | Experimental | Other: Mother's Voice, Other: Mother's Voice +Therapeutic Touch, Other: ControlTherapeutic touch was started 5 minutes before nasal prongs were placed, and was applied for 5 minutes during the application, and continued for another 5 minutes after the nasal prongs were placed. The method was applied for a total of 15 minutes as 5 minutes of hand resting, 5 minutes of gentle caressing and 5 more minutes of hand resting.The NIPS and PICS scores were evaluated and recorded before, during and after the application. |
| Mother's Voice+Therapeutic Touch | Experimental | Other: Mother's Voice, Other: Therapeutic Touch, Other: ControlBoth applications were applied together for 15 minutes.The NIPS and PICS scores were evaluated and recorded before, during and after the application. |
| Control | No intervention | –The premature babies in the control group did not receive any intervention other than the hospital procedure.The NIPS and PICS scores were evaluated and recorded before, during and after the application. |
Who may qualify
- Ages
- 28 to 37 weeks
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- being checked in at Neonatal Intensive Care Unit
- being in the gestational ages of 28 to 37 weeks
- having nasal CPAP
Key exclusion criteria (6 listed)
- having neurological disorders
- having comorbidity
- receiving sedation or analgesics
- having congenital anomaly
- receiving extra invasive procedures or surgical intervention
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 |
|---|---|---|
| Mother's VoiceAlso: Mother's Voice GroupThe audio recording was made to listen to the baby for 15 minutes during the nasal CPAP application. The NIPS and PICS scores were evaluated and recorded before, during and after the application. | Other | Mother's Voice+Therapeutic Touch, Therapeutic Touch |
| Therapeutic TouchAlso: Therapeutic Touch GroupTherapeutic touch was started 5 minutes before nasal prongs were placed, and was applied for 5 minutes during the application, and continued for another 5 minutes after the nasal prongs were placed. The method was applied for a total of 15 minutes as 5 minutes of hand resting, 5 minutes of gentle caressing and 5 more minutes of hand resting.The NIPS and PICS scores were evaluated and recorded before, during and after the application. | Other | Mother's Voice, Mother's Voice+Therapeutic Touch |
| Mother's Voice +Therapeutic TouchAlso: Mother's Voice +Therapeutic Touch GroupBoth applications were applied together for 15 minutes.The NIPS and PICS scores were evaluated and recorded before, during and after the application. | Other | Mother's Voice, Therapeutic Touch |
| ControlAlso: Control GroupThe premature babies in the control group did not receive any intervention other than the hospital procedure.The NIPS and PICS scores were evaluated and recorded before, during and after the application. | Other | Mother's Voice, Mother's Voice+Therapeutic Touch, Therapeutic Touch |
Primary outcome
Neonatal Infant Pain Scale (NIPS)
Time frame: 15 minutes
Neonatal Infant Pain Scale (NIPS) was developed by Lawrence et. al. in 1993 in order to assess intervention-related pain in term and preterm babies (Lawrence et al., 1993). The Turkish validity and reliability of the study was conducted in 1999 by Akdovan (Akdovan, 1999). NIPS has six sections on facial expression, crying, respiration state, movements of extremity, and being awake. All behavioral responses except for crying were given two separate scores (0-1 score). Three separate scores were assigned (0-1-2) to crying. The total scores were between 0-7. A high score showed that pain was more intense (Yilmaz \& Arikan, 2011). The Cronbach's a coefficients before, during, and after the intervention were found to be 0.95, 0.87, and 0.88, respectively, by Lawrence et al. (Lawrence et al., 1993).The Neonatal Infant Pain Scale (NIPS) score was evaluated and recorded before, during and 15 minutes after the application.
Premature Infant Comfort Scale (PICS)
Time frame: 15 minutes
Premature Infant Comfort Scale (PICS) which was developed by Ambuel et. al. (Ambuel et al., 1992) in order to the measure pain and stress levels of 0-18-month-old children, was later adapted to 28-37-week-old premature infants by Monique et. al. in 2007 (Caljouw et al., 2007) The Premature Infant Comfort Scale assesses 7 parameters such as Awareness, Tranquility/Agitation, Respiration State (only supported by mechanical ventilation) or Crying (it was not assessed because it was scored only in children with spontaneous respiration), Physical Movement, Muscular Tonus, Facial Expressions and Average Cardiac Beat. The scale is 5-point Likert type. As the scale score increases, the comfort level decreases. The scores are between 35 and 7. Comfort decreases as it approaches 35 points, and increases as it approaches 7 points. (Küçük Alemdar \& Güdücü Tüfekci, 2015).Premature Infant Comfort Scale (PICS) score was evaluated and recorded before, during and 15 minutes after the application.
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 13 Oct 2022.
- Individual participant dataSharing planned: No
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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.
Ayşe Belpınar, Msc principal investigator
Bozok University
Emriye Hilal Yayan, Phd principal investigator
Inonu University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mother's Voice, Therapeutic Touch and Mother's Voice +Therapeutic Touch in people with Preterm Infants and Nasal Continuous Positive Airway Pressure, run by Ayşe Belpınar 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 3 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 13 Oct 2022. 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?
Neonatal Infant Pain Scale (NIPS) (time frame: 15 minutes). 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 13 Oct 2022.