Pain ManagementNCT05143450
Efficacy of Manual Pressure in Infants
A study testing Manual Pressure in people with Pain Management, run by Biruni University at 1 site in Turkey (Türkiye).
Trial summary
Manual pressure is an effective, easy-to-apply, no preparation, and cost-effective method of reducing pain associated with the injection. This study will be carried out to determine the effect of manual pressure applied to the injection site on the pain level and crying time of the infants before the injection of the… Read more about this study
- Who is it for?
- Ages 4 to 4 months
- Conditions the study is for
- Pain Management
- What is being tested?
- Manual Pressure
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Dec 2021to 2 Jun 2022
- 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 4 to 4 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Being a healthy baby born at term
- Being 4 months old
- Having no chronic disease,
- Having no neurological disease.
- Not taking an analgesic drug within 24 hours before vaccination.
Who cannot join
- Being an unhealthy baby born at preterm or post-term,
- Being younger or older than 4 months old,
- Having a chronic disease,
- Having a neurological disease,
- Taking an analgesic drug within 24 hours before vaccination.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Applying Manual Pressure Before Vaccination on Pain and Crying Time in Infants
Manual pressure is an effective, easy-to-apply, no preparation, and cost-effective method of reducing pain associated with the injection. This study will be carried out to determine the effect of manual pressure applied to the injection site on the pain level and crying time of the infants before the injection of the Diphtheria-Tetanus-Acellular Pertussis Vaccine (DTaP), Inactivated Polio Vaccine (IPV), and Haemophilus Influenzae Type b Vaccine (Hib) (5-in-1) in 2-month-old infants. The study will be conducted with the randomized controlled experimental method. Before the procedure, manual pressure will be applied to the injection site with the thumb for 10 seconds to the infants in the experimental group. No non-pharmacological method will be used before vaccination to the infants in the control group. Pain scores of infants in the intervention and control groups will be evaluated before, during, and after vaccination. In addition, the total crying times of the babies will be calculated and recorded with a stopwatch.
Read the detailed description
Vaccine injection is one of the most common causes of pain in healthy infants and children. Parents may avoid or delay vaccination to avoid the pain their child experiences repeatedly with vaccination. Avoiding or delaying vaccination by parents may lead to disruption of vaccination programs, and thus an increase in infectious diseases that can be prevented by vaccination. Therefore, the management of pain due to vaccine injection in children is very important. Many non-pharmacological methods are used to control vaccine-related pain in children. Manual pressure, which is one of these methods, is applied to the injection area with the thumb for 10 seconds before the injection. The pain control effect of manual pressure is explained by the gate control theory. According to this theory, the presence and severity of pain depend on the transmission of neurological stimuli. In summary, if the door is open, the warnings reach the level of consciousness and pain is felt, if it is closed, the warnings do not reach the consciousness and pain is not felt. Applications such as rubbing the pain area, pressing with a finger, massage provide closing the door to painful stimuli. The aim of the study is to determine the effect of manual pressure applied to the injection site on the pain level and crying time of the infants before the injection of the DTaP-IPV-Hib vaccine (5-in-1) in 2-month-old infants.The sample size of the study has been determined by the power analysis (G*Power 3.1.9.2), in line with the results obtained from the studies which have been conducted using a similar research method. The sample size was found to be a total of 66 children including minimum of 33 children for each group. It was estimated that case losses may occur and therefore, it was decided to conduct the study with a total of 70 children including 35 children in two groups. Information Form, Face, Legs, Activity, Cry, Consolability (FLACC) Scale, and chronometer will use for data collection. Children's parents who applied to the Kumkapi Family Health Center will be given information about the study. Information about children and their parents included in the study will ask by the researcher through face-to-face interviews and these data will record in 'Information Form' five minutes before the procedure.
Before the procedure, manual pressure will be applied to the injection site with the thumb for 10 seconds to the infants in the experimental group. No non-pharmacological method will be used before vaccination to the infants in the control group. The latero-femoral region (vastus lateralis muscle) will be used as the injection site for vaccination. All infants in the intervention and control groups will be accompanied by their parents throughout the procedure. In addition, the chronometer will be started when the baby starts to cry, and the chronometer will be stopped when the crying stops. Total crying time will be recorded on the Information Form. Before, during, and after vaccination children's pain will evaluate with the FLACC Scale by the healthcare provider who performs the injection. Before and during venipuncture children's pain will evaluate with the FLACC Scale and their emotional status will evaluate with the Children's Emotional Manifestation Scale by the healthcare provider who performs the venipuncture procedure.
- Conditions
- Pain Management
- Being tested
- Manual Pressure
- Keywords
- injection, manual pressure, pain, pain management, vaccination
- Medical subject headings
- Agnosia, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Manual PressureOther
In the experimental group manual pressure will be applied to the injection site with the thumb for 10 seconds to the infants by the researcher before the procedure. Manual pressure reduces pain within the framework of the gate control theory. According to the gate control theory, when pressure is applied to an area, a fiber transmits the feeling of pressure instead of pain and ultimately the pain sensation is alleviated.
| Study group | Role | What they receive |
|---|---|---|
| Experimental Group | Experimental | Before the procedure, manual pressure will be applied to the injection site with the thumb for 10 seconds to the infants by the researcher. Receives: Other: Manual Pressure |
| Control Group | No intervention | No intervention will perform to reduce pain in the control group. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of Pain
Pain will assess by the healthcare provider who performs the venipuncture procedure with the FLACC (Face, Legs, Activity, Cry, Consolability) Scale. This scale was developed to evaluate the pain of children aged 2 months to 7 years. The child's facial expression, leg movements, activity, crying, and comfortability behaviors are evaluated in relation to pain. These five behaviors are rated with 0, 1, or 2 points. The total score of the scale ranges from 0 to 10, and a high score indicates that the child has more pain. '0' points from the scale indicate no pain, '1-3' points indicate mild pain, '4-6' points indicate moderate pain, and '7-10' points indicate severe pain.
Measured: Before vaccine injection, when the vaccine starts to be injected and immediately after the injector was removed.
Secondary outcomes (1)
Crying time
Crying time throughout vaccine injections will be calculated for each infant using a chronometer.
Measured: During vaccine injection and immediately after injection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2021
- Study start15 Dec 2021
- Primary completion2 Jun 2022
- Study completion2 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pain ManagementStudies of the same condition, open and under way.
- More trials run by Biruni 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
- Masking
- None (open label)
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Biruni University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zeynep Erkut, Biruni University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05143450
- Sponsor's protocol ID
- 2015-KAEK-53-21-02
- Status last verified
- Nov 2021
- First submitted
- 17 Nov 2021
- Last updated
- 15 Jun 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Applying Manual Pressure Before Vaccination on Pain and Crying Time in Infants
- ClinicalTrials.gov ID
- NCT05143450
- Acronym / sponsor ID
- 2015-KAEK-53-21-02
- Conditions
- Pain Management
- Keywords
- injection, manual pressure, pain, pain management, vaccination
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Biruni UniversityUniversity, hospital or other
- Study start
- 15 Dec 2021 (actual)
- Primary completion
- 2 Jun 2022 (actual)
- Study completion
- 2 Jun 2022 (actual)
- First posted
- 3 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.
Manual pressure is an effective, easy-to-apply, no preparation, and cost-effective method of reducing pain associated with the injection. This study will be carried out to determine the effect of manual pressure applied to the injection site on the pain level and crying time of the infants before the injection of the Diphtheria-Tetanus-Acellular Pertussis Vaccine (DTaP), Inactivated Polio Vaccine (IPV), and Haemophilus Influenzae Type b Vaccine (Hib) (5-in-1) in 2-month-old infants. The study will be conducted with the randomized controlled experimental method. Before the procedure, manual pressure will be applied to the injection site with the thumb for 10 seconds to the infants in the experimental group. No non-pharmacological method will be used before vaccination to the infants in the control group. Pain scores of infants in the intervention and control groups will be evaluated before, during, and after vaccination. In addition, the total crying times of the babies will be calculated and recorded with a stopwatch.
Detailed description
Vaccine injection is one of the most common causes of pain in healthy infants and children. Parents may avoid or delay vaccination to avoid the pain their child experiences repeatedly with vaccination. Avoiding or delaying vaccination by parents may lead to disruption of vaccination programs, and thus an increase in infectious diseases that can be prevented by vaccination. Therefore, the management of pain due to vaccine injection in children is very important. Many non-pharmacological methods are used to control vaccine-related pain in children. Manual pressure, which is one of these methods, is applied to the injection area with the thumb for 10 seconds before the injection. The pain control effect of manual pressure is explained by the gate control theory. According to this theory, the presence and severity of pain depend on the transmission of neurological stimuli. In summary, if the door is open, the warnings reach the level of consciousness and pain is felt, if it is closed, the warnings do not reach the consciousness and pain is not felt. Applications such as rubbing the pain area, pressing with a finger, massage provide closing the door to painful stimuli. The aim of the study is to determine the effect of manual pressure applied to the injection site on the pain level and crying time of the infants before the injection of the DTaP-IPV-Hib vaccine (5-in-1) in 2-month-old infants.The sample size of the study has been determined by the power analysis (G*Power 3.1.9.2), in line with the results obtained from the studies which have been conducted using a similar research method. The sample size was found to be a total of 66 children including minimum of 33 children for each group. It was estimated that case losses may occur and therefore, it was decided to conduct the study with a total of 70 children including 35 children in two groups. Information Form, Face, Legs, Activity, Cry, Consolability (FLACC) Scale, and chronometer will use for data collection. Children's parents who applied to the Kumkapi Family Health Center will be given information about the study. Information about children and their parents included in the study will ask by the researcher through face-to-face interviews and these data will record in 'Information Form' five minutes before the procedure.
Before the procedure, manual pressure will be applied to the injection site with the thumb for 10 seconds to the infants in the experimental group. No non-pharmacological method will be used before vaccination to the infants in the control group. The latero-femoral region (vastus lateralis muscle) will be used as the injection site for vaccination. All infants in the intervention and control groups will be accompanied by their parents throughout the procedure. In addition, the chronometer will be started when the baby starts to cry, and the chronometer will be stopped when the crying stops. Total crying time will be recorded on the Information Form. Before, during, and after vaccination children's pain will evaluate with the FLACC Scale by the healthcare provider who performs the injection. Before and during venipuncture children's pain will evaluate with the FLACC Scale and their emotional status will evaluate with the Children's Emotional Manifestation Scale by the healthcare provider who performs the venipuncture procedure.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental Group | Experimental | Other: Manual PressureBefore the procedure, manual pressure will be applied to the injection site with the thumb for 10 seconds to the infants by the researcher. |
| Control Group | No intervention | –No intervention will perform to reduce pain in the control group. |
Who may qualify
- Ages
- 4 to 4 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Being a healthy baby born at term
- Being 4 months old
- Having no chronic disease,
- Having no neurological disease.
- Not taking an analgesic drug within 24 hours before vaccination.
Key exclusion criteria (5 listed)
- Being an unhealthy baby born at preterm or post-term,
- Being younger or older than 4 months old,
- Having a chronic disease,
- Having a neurological disease,
- Taking an analgesic drug within 24 hours before vaccination.
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 |
|---|---|---|
| Manual PressureIn the experimental group manual pressure will be applied to the injection site with the thumb for 10 seconds to the infants by the researcher before the procedure. Manual pressure reduces pain within the framework of the gate control theory. According to the gate control theory, when pressure is applied to an area, a fiber transmits the feeling of pressure instead of pain and ultimately the pain sensation is alleviated. | Other | Experimental Group |
Primary outcome
Change of Pain
Time frame: Before vaccine injection, when the vaccine starts to be injected and immediately after the injector was removed.
Pain will assess by the healthcare provider who performs the venipuncture procedure with the FLACC (Face, Legs, Activity, Cry, Consolability) Scale. This scale was developed to evaluate the pain of children aged 2 months to 7 years. The child's facial expression, leg movements, activity, crying, and comfortability behaviors are evaluated in relation to pain. These five behaviors are rated with 0, 1, or 2 points. The total score of the scale ranges from 0 to 10, and a high score indicates that the child has more pain. '0' points from the scale indicate no pain, '1-3' points indicate mild pain, '4-6' points indicate moderate pain, and '7-10' points indicate severe pain.
1 secondary outcome
Crying time
Time frame: During vaccine injection and immediately after injection
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 Jun 2022.
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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 Manual Pressure in people with Pain Management, run by Biruni 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 5 inclusion and 5 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 Jun 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?
Change of Pain (time frame: Before vaccine injection, when the vaccine starts to be injected and immediately after the injector was removed.). 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 15 Jun 2022.