Interventions PainNCT04643730
The Effects on Pain of Acupressure and Foot Reflexology Before Heel Lancing in Newborns
A study testing Acupressure methods and Foot Reflexology Methods in people with Interventions Pain, run by Eskisehir Osmangazi University at 1 site in Turkey (Türkiye).
Trial summary
This study aimed to determine the effects of foot reflexology and acupressure on the KI3 and St36 points on pain during interventions when these procedures were administered before heel lancing in term newborns. Read more about this study
- Who is it for?
- Ages 24 hours and olderHealthy volunteers can take part
- Conditions the study is for
- Interventions Pain
- What is being tested?
- Acupressure methods and Foot Reflexology Methods
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 105 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 30 Oct 2017to 30 Mar 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 24 hours and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Being born by cesarean section,
- Being a term newborn,
- Being completed the 24th hour of the postnatal period,
- Staying with birth mother,
- Being fed in the last half hour before the procedure,
- Having a heel prick performed by the same nurse,
- Giving blood on the first try (because pain level may change on the second try),
- Having a mother who gave written informed consent
Who cannot join
- Having no health problem,
- Being underwent more than 2 invasive interventions,
- Receiving an analgesic/sedative drug in the 8 hours before the application.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomised Controlled Study: The Effects on Pain of Foot Reflexology and Acupressure During Heel Lancing In Newborns
This study aimed to determine the effects of foot reflexology and acupressure on the KI3 and St36 points on pain during interventions when these procedures were administered before heel lancing in term newborns.
- Conditions
- Interventions Pain
- Being tested
- Acupressure methods, Foot Reflexology Methods, Control Grup
- Keywords
- Newborn,, pain,, heel lance,, foot reflexology,, acupressure,, nurse
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Acupressure methodsOther
Acupressure on the KI3 and St36 points applied to the babies in the acupressure group for a total of 7 minutes before the heel prick
Foot Reflexology MethodsOther
Foot reflexology was applied to the babies in the foot reflexology group for a total of 7 minutes before the heel prick
Control GrupOther
No pre-application was made to the babies in the control group as a routine procedure.
| Study group | Role | What they receive |
|---|---|---|
| Reflexology Group | Experimental | Foot Reflexology was applied to the babies before heel lancing Receives: Other: Foot Reflexology Methods |
| Acupressure Group | Experimental | Acupressure was applied to the babies before heel lancing Receives: Other: Acupressure methods |
| Control Group | Active comparator | No pre-application was made to the babies in the control group as a routine procedure Receives: Other: Control Grup |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain levels of the newborns
The N-PASS was developed by Hummel et al. in 2003 to be used in all full-term and preterm neonates. The scale was revised by Hummel on October 2, 2009 and adapted to Turkish by Açıkgöz et al. in 2011 The Cronbach's alpha internal consistency coefficient of the scale was found to be 0.779 for preintervention and 0.917 for postintervention (Açıkgöz et al., 2017). The N-PASS consists of five sub-dimensions: crying and irritability, behavior-state, facial expression, extremities tone, and vital signs. The sub-dimension of vital signs was evaluated according to infants' heart rates and oxygen saturation values. The total pain score that can be obtained from the scale ranges between 0 and +10. A higher score indicates that the severity of pain is high. The goal of pain therapy is to keep the score at or below 3 (Hummel et al., 2008; Hummel et al., 2010).
Measured: Before the pain procedure, during the pain procedure (the pain levels of the infants when the needle pricked the heel were evaluated using the N-PASS) and After the pain procedure. (Having completed the 24th hour of the postnatal period)
Secondary outcomes (3)
Changes in oxygen saturation
Recorded the changes in oxygen saturation (SpO2) of newborns (Having completed the 24th hour of the postnatal period) before (A pulse oximeter was attached to the infants two minutes before the procedure), during and after pain procedure
Measured: 2 Minutes
Changes in heart rates
Recorded the changes in Heart rate of newborns (Having completed the 24th hour of the postnatal period) before (A pulse oximeter was attached to the infants two minutes before the procedure), during and after pain procedure
Measured: 2 Minutes
Percentage of crying during heel prick in healthy term neonates
Percentage of crying in 3 groups were applied during heel prick and immediately after intervention. Results are shown as mean.
Measured: During heel prick and immediately after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Nov 2020
- Study start30 Oct 2017
- Primary completion30 Mar 2018
- Study completion30 Mar 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Interventions 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
- Factorial
- Masking
- None (open label)
- Enrolment
- 105 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eskisehir Osmangazi University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ayşe Özge DENİZ, Eskisehir Osmangazi University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04643730
- Sponsor's protocol ID
- Ayşe Özge DENİZ
- Status last verified
- Nov 2020
- First submitted
- 10 Oct 2020
- Last updated
- 25 Nov 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Hummel P, Puchalski M, Creech SD, Weiss MG. Clinical reliability and validity of the N-PASS: neonatal pain, agitation and sedation scale with prolonged pain. J Perinatol. 2008 Jan;28(1):55-60. doi: 10.1038/sj.jp.7211861. Epub 2007 Oct 25.
PubMed 18165830Hummel P, Lawlor-Klean P, Weiss MG. Validity and reliability of the N-PASS assessment tool with acute pain. J Perinatol. 2010 Jul;30(7):474-8. doi: 10.1038/jp.2009.185. Epub 2009 Nov 19.
PubMed 19924132Açıkgöz, A., Çiğdem, Z., Yıldız, S., Demirüstü, C., Yarar, M., & Aksit, A. (2017). A Turkish Adaptation of the Neonatal Pain/Agitation, Sedation Scale (N-PASS) and its Validity and Reliability, Indian Journal of Fundamental and Applied Life Sciences, 7(2): 5-11
Deniz AO, Acikgoz A. A Randomized Controlled Trial: The Effect of Acupressure and Foot Reflexology on Pain During Heel-Lancing in Neonates. Clin Nurs Res. 2023 Feb;32(2):306-312. doi: 10.1177/10547738211061815. Epub 2021 Dec 26.
PubMed 34955035
Study at a glance
From the registry record, last updated by the sponsor on 25 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomised Controlled Study: The Effects on Pain of Foot Reflexology and Acupressure During Heel Lancing In Newborns
- ClinicalTrials.gov ID
- NCT04643730
- Acronym / sponsor ID
- Ayşe Özge DENİZ
- Conditions
- Interventions Pain
- Keywords
- Newborn,, pain,, heel lance,, foot reflexology,, acupressure,, nurse
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 105 participants (actual)
- Lead sponsor
- Eskisehir Osmangazi UniversityUniversity, hospital or other
- Study start
- 30 Oct 2017 (actual)
- Primary completion
- 30 Mar 2018 (actual)
- Study completion
- 30 Mar 2018 (actual)
- First posted
- 25 Nov 2020 (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 aimed to determine the effects of foot reflexology and acupressure on the KI3 and St36 points on pain during interventions when these procedures were administered before heel lancing in term newborns.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Reflexology Group | Experimental | Other: Foot Reflexology MethodsFoot Reflexology was applied to the babies before heel lancing |
| Acupressure Group | Experimental | Other: Acupressure methodsAcupressure was applied to the babies before heel lancing |
| Control Group | Active comparator | Other: Control GrupNo pre-application was made to the babies in the control group as a routine procedure |
Who may qualify
- Ages
- 24 hours and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (8 listed)
- Being born by cesarean section,
- Being a term newborn,
- Being completed the 24th hour of the postnatal period,
- Staying with birth mother,
- Being fed in the last half hour before the procedure,
Key exclusion criteria (3 listed)
- Having no health problem,
- Being underwent more than 2 invasive interventions,
- Receiving an analgesic/sedative drug in the 8 hours before the application.
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 |
|---|---|---|
| Acupressure methodsAcupressure on the KI3 and St36 points applied to the babies in the acupressure group for a total of 7 minutes before the heel prick | Other | Acupressure Group |
| Foot Reflexology MethodsFoot reflexology was applied to the babies in the foot reflexology group for a total of 7 minutes before the heel prick | Other | Reflexology Group |
| Control GrupNo pre-application was made to the babies in the control group as a routine procedure. | Other | Control Group |
Primary outcome
Pain levels of the newborns
Time frame: Before the pain procedure, during the pain procedure (the pain levels of the infants when the needle pricked the heel were evaluated using the N-PASS) and After the pain procedure. (Having completed the 24th hour of the postnatal period)
The N-PASS was developed by Hummel et al. in 2003 to be used in all full-term and preterm neonates. The scale was revised by Hummel on October 2, 2009 and adapted to Turkish by Açıkgöz et al. in 2011 The Cronbach's alpha internal consistency coefficient of the scale was found to be 0.779 for preintervention and 0.917 for postintervention (Açıkgöz et al., 2017). The N-PASS consists of five sub-dimensions: crying and irritability, behavior-state, facial expression, extremities tone, and vital signs. The sub-dimension of vital signs was evaluated according to infants' heart rates and oxygen saturation values. The total pain score that can be obtained from the scale ranges between 0 and +10. A higher score indicates that the severity of pain is high. The goal of pain therapy is to keep the score at or below 3 (Hummel et al., 2008; Hummel et al., 2010).
3 secondary outcomes
Changes in oxygen saturation
Time frame: 2 Minutes
Changes in heart rates
Time frame: 2 Minutes
Percentage of crying during heel prick in healthy term neonates
Time frame: During heel prick and immediately after intervention
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 25 Nov 2020.
- Background: PubMed 18165830Hummel P, Puchalski M, Creech SD, Weiss MG. Clinical reliability and validity of the N-PASS: neonatal pain, agitation and sedation scale with prolonged pain. J Perinatol. 2008 Jan;28(1):55-60. doi: 10.1038/sj.jp.7211861. Epub 2007 Oct 25.
- Background: PubMed 19924132Hummel P, Lawlor-Klean P, Weiss MG. Validity and reliability of the N-PASS assessment tool with acute pain. J Perinatol. 2010 Jul;30(7):474-8. doi: 10.1038/jp.2009.185. Epub 2009 Nov 19.
- BackgroundAçıkgöz, A., Çiğdem, Z., Yıldız, S., Demirüstü, C., Yarar, M., & Aksit, A. (2017). A Turkish Adaptation of the Neonatal Pain/Agitation, Sedation Scale (N-PASS) and its Validity and Reliability, Indian Journal of Fundamental and Applied Life Sciences, 7(2): 5-11
- Derived from this study: PubMed 34955035Deniz AO, Acikgoz A. A Randomized Controlled Trial: The Effect of Acupressure and Foot Reflexology on Pain During Heel-Lancing in Neonates. Clin Nurs Res. 2023 Feb;32(2):306-312. doi: 10.1177/10547738211061815. Epub 2021 Dec 26.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Acupressure methods and Foot Reflexology Methods in people with Interventions Pain, run by Eskisehir Osmangazi University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 3 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 25 Nov 2020. 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 levels of the newborns (time frame: Before the pain procedure, during the pain procedure (the pain levels of the infants when the needle pricked the heel were evaluated using the N-PASS) and After the pain procedure. (Having completed the 24th hour of the postnatal period)). 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 NCT04643730, which also lists 4 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 25 Nov 2020.