Acute PainNCT03906552
Effects of Acupressure and Foot Massage on Pain During Heel Lancing in Neonates
A study testing nonpharmalogocial methods in people with Acute Pain, run by Adiyaman University Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
Aim: The study was aimed to identifying the effects of foot massage and acupressure on pain during heel lancing in neonates. Methods: A single-blinded randomized controlled trial was performed in a university hospital in Turkey between April-December 2018. Read more about this study
- Who is it for?
- Ages 1 day to 2 daysHealthy volunteers can take part
- Conditions the study is for
- Acute Pain
- What is being tested?
- nonpharmalogocial methods
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 139 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 23 Jan 2018to 1 Dec 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 1 day to 2 days
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- having 2500-4000 gr body weight and being term neonates,
- having APGAR score of over 7 five minutes after birth,
- having no health problems detected in the newborn examination after birth,
- having received no painful interventions apart from Hepatitis B and Kvit after birth,
- being with the mother and being fed orally,
- having had breast milk within 30 minutes before heel lancing
- having a clean diaper.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Adiyaman University
Aim: The study was aimed to identifying the effects of foot massage and acupressure on pain during heel lancing in neonates.
Methods: A single-blinded randomized controlled trial was performed in a university hospital in Turkey between April-December 2018. Neonates were randomized into three groups as acupressure, massage and control groups. Data were obtained by using Information form, Neonatal Infant Pain Scale (NIPS), pulse oximeter device and chronometer. Acupressure was applied to the neonates in the acupressure group and massage was given to the neonates in the massage group for 2 minutes before heel lancing procedure. Pain levels of the neonates in the groups were evaluated during and 1 minute after heel lancing procedure. Furthermore, the oxygen saturation and heart rate values of the neonates in the groups were measured by pulse oximeter device before, during and after heel lancing procedure. Duration of crying and heel lancing procedure were recorded by chronometer.
Read the detailed description
Massage is a systematic and scientific procedure applied by using hands or special tools. As for acupressure, it is a method applied by stimulating the acupuncture points using hands and fingers by applying pressure on the meridians in body.Both methods are reliable, economic and easy to learn and apply. Review of the related literature indicates studies on the effectiveness of acupressure and foot massage on reducing pain in neonates.
- Conditions
- Acute Pain
- Being tested
- nonpharmalogocial methods
- Keywords
- acupressure, massage, pain, neonate, heel lancing
- Medical subject headings
- Acute Pain, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
nonpharmalogocial methodsOther
neonates received acupressure (acupressure group) or massage (massage group) before heel lancing procedure
| Study group | Role | What they receive |
|---|---|---|
| acupressure group | Experimental | 2 neonates did not calm down before heel lancing; oxygen saturation and heart rate values of 2 neonates could not be monitored because the pulse oximeter tool probe was not fastened well.
Acupressure was performed when the mother was holding the neonate on her arm. For two minutes, acupressure was performed in the acupressure points (Kun Lun (UB60) and Taixi (K3). Each point was applied acupressure for 60 seconds, and heel lancing was performed right after this procedure. The acupuncture points that Kun Lun (UB60) and Taixi (K3) are on the side of the ankle. Receives: Other: nonpharmalogocial methods |
| masssage group | Experimental | oxygen saturation and heart rate values of 2 neonates could not be monitored because the pulse oximeter tool probe was not fastened well; heel lancing could not be performed at the first attempt (2 neonates).
Foot massage was performed when the mother was holding the neonate on her arm. Each neonate was given foot massage for two minutes, and heel lancing was performed right after the massage. Receives: Other: nonpharmalogocial methods |
| control group | No intervention | oxygen saturation and heart rate values of 1 neonates could not be monitored because the pulse oximeter tool probe was not fastened well; heel lancing could not be performed at the first attempt (2 neonates). No application was made to theneonates in the control group before heel lancing procedure |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain Scale
Neonatal Infant Pain Scale (NIPS): The scale was developed by Lawrence et al. in 1993 in order to asses the behavioral and physiological pain responses of premature and term neonates. The scale consists of five behavioral and one physiological sections including facial expression, crying, breathing, arm and leg movements, and alertness. Total scores range between 0 and 7. Scores from 0 to 2 indicate mild to no pain, 3 to 4 indicates mild to moderate pain, and >4 indicates severe pain. Higher scores indicate more severe pain. In the study of Lawrence et al., NIPS 's Cronbach's Alpha 0.92 found (Larwence et al. 1993). The scale was adapted to Turkish by Akdovan, NIPS is used for the assessment of procedural pain of the premature and term neonates. Akdovan found the Cronbach's Alpha value to be 0.83. The pain intensity of neonates was evaluated during and 1 minute after heel lancing procedure
Measured: 1 minute
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2019
- Study start23 Jan 2018
- Primary completion23 Jan 2018
- Study completion1 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute 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
- Model description
- randomized controlled trial
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 139 participants (actual)
Sponsor and investigators
- Lead sponsor
- Adiyaman University Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tuba Koc Ozkan, Adiyaman University Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03906552
- Sponsor's protocol ID
- 2018/1-5
- Status last verified
- Apr 2019
- First submitted
- 4 Apr 2019
- Last updated
- 8 Apr 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adiyaman University
- ClinicalTrials.gov ID
- NCT03906552
- Acronym / sponsor ID
- 2018/1-5
- Conditions
- Acute Pain
- Keywords
- acupressure, massage, pain, neonate, heel lancing
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 139 participants (actual)
- Lead sponsor
- Adiyaman University Research HospitalUniversity, hospital or other
- Study start
- 23 Jan 2018 (actual)
- Primary completion
- 23 Jan 2018 (actual)
- Study completion
- 1 Dec 2018 (actual)
- First posted
- 8 Apr 2019 (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: The study was aimed to identifying the effects of foot massage and acupressure on pain during heel lancing in neonates.
Methods: A single-blinded randomized controlled trial was performed in a university hospital in Turkey between April-December 2018. Neonates were randomized into three groups as acupressure, massage and control groups. Data were obtained by using Information form, Neonatal Infant Pain Scale (NIPS), pulse oximeter device and chronometer. Acupressure was applied to the neonates in the acupressure group and massage was given to the neonates in the massage group for 2 minutes before heel lancing procedure. Pain levels of the neonates in the groups were evaluated during and 1 minute after heel lancing procedure. Furthermore, the oxygen saturation and heart rate values of the neonates in the groups were measured by pulse oximeter device before, during and after heel lancing procedure. Duration of crying and heel lancing procedure were recorded by chronometer.
Detailed description
Massage is a systematic and scientific procedure applied by using hands or special tools. As for acupressure, it is a method applied by stimulating the acupuncture points using hands and fingers by applying pressure on the meridians in body.Both methods are reliable, economic and easy to learn and apply. Review of the related literature indicates studies on the effectiveness of acupressure and foot massage on reducing pain in neonates.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (investigator)
- Number of arms
- 3
- Model description
- randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| acupressure group | Experimental | Other: nonpharmalogocial methods2 neonates did not calm down before heel lancing; oxygen saturation and heart rate values of 2 neonates could not be monitored because the pulse oximeter tool probe was not fastened well. Acupressure was performed when the mother was holding the neonate on her arm. For two minutes, acupressure was performed in the acupressure points (Kun Lun (UB60) and Taixi (K3). Each point was applied acupressure for 60 seconds, and heel lancing was performed right after this procedure. The acupuncture points that Kun Lun (UB60) and Taixi (K3) are on the side of the ankle. |
| masssage group | Experimental | Other: nonpharmalogocial methodsoxygen saturation and heart rate values of 2 neonates could not be monitored because the pulse oximeter tool probe was not fastened well; heel lancing could not be performed at the first attempt (2 neonates). Foot massage was performed when the mother was holding the neonate on her arm. Each neonate was given foot massage for two minutes, and heel lancing was performed right after the massage. |
| control group | No intervention | –oxygen saturation and heart rate values of 1 neonates could not be monitored because the pulse oximeter tool probe was not fastened well; heel lancing could not be performed at the first attempt (2 neonates). No application was made to theneonates in the control group before heel lancing procedure |
Who may qualify
- Ages
- 1 day to 2 days
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- having 2500-4000 gr body weight and being term neonates,
- having APGAR score of over 7 five minutes after birth,
- having no health problems detected in the newborn examination after birth,
- having received no painful interventions apart from Hepatitis B and Kvit after birth,
- being with the mother and being fed orally,
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| nonpharmalogocial methodsneonates received acupressure (acupressure group) or massage (massage group) before heel lancing procedure | Other | acupressure group, masssage group |
Primary outcome
Pain Scale
Time frame: 1 minute
Neonatal Infant Pain Scale (NIPS): The scale was developed by Lawrence et al. in 1993 in order to asses the behavioral and physiological pain responses of premature and term neonates. The scale consists of five behavioral and one physiological sections including facial expression, crying, breathing, arm and leg movements, and alertness. Total scores range between 0 and 7. Scores from 0 to 2 indicate mild to no pain, 3 to 4 indicates mild to moderate pain, and >4 indicates severe pain. Higher scores indicate more severe pain. In the study of Lawrence et al., NIPS 's Cronbach's Alpha 0.92 found (Larwence et al. 1993). The scale was adapted to Turkish by Akdovan, NIPS is used for the assessment of procedural pain of the premature and term neonates. Akdovan found the Cronbach's Alpha value to be 0.83. The pain intensity of neonates was evaluated during and 1 minute after heel lancing procedure
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 8 Apr 2019.
- Individual participant dataSharing planned: Undecided
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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 nonpharmalogocial methods in people with Acute Pain, run by Adiyaman University Research Hospital 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 0 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 8 Apr 2019. 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 Scale (time frame: 1 minute). 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 8 Apr 2019.