PainacupressureNCT06163196
The Effect of Acupressure on Pain in Children With Thalassemia
A study testing acupressure in people with Pain, run by Mersin University at 1 site in Turkey (Türkiye).
Trial summary
This randomized controlled trial evaluates the effect of acupressure on reducing the pain of blood collection in children with Thalassemia. The hypothesis of this study is that acupressure application reduces acute pain. Read more about this study
- Who is it for?
- Ages 6 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Pain
- What is being tested?
- acupressure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 39 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 4 Jun 2022to 4 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 6 to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Registered in the centers where the study will be carried out,
- Able to communicate verbally
- No developmental or sensory disabilities,
- No mental illness
- No opioid, narcotic analgesic or sedative use in the last 8 hours before the procedure,
- No other chronic disease
- One-time bloodletting
- Children who agree to participate in the study.
Who cannot join
- Having pain before the blood draw procedure,
- Not between the ages of 6-18,
- Have developmental or sensory disabilities,
- Having a mental illness
- Using opioids, narcotic analgesics or sedatives in the last 8 hours before the procedure,
- Having another chronic disease,
- One-time blood sampling is not performed,
- Fractures or signs of inflammation at acupressure application points
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect Of Acupressure Application On Reducing Pain During Venipuncture İn Children Dıagnosed With Thalassemia.
This randomized controlled trial evaluates the effect of acupressure on reducing the pain of blood collection in children with Thalassemia. The hypothesis of this study is that acupressure application reduces acute pain.
Read the detailed description
A total of 39 children with a diagnosis of Thalassemia were randomly assigned to the study and control groups. In the study group (n:19), blood pressure, pulse and oxygen saturation were measured, and the acupressure points determined (large intestine meridian 4. Point: LI 4, large intestine meridian 11. Point: LI 11, Heart Meridian 7. Point: HT 7 ) acupressure was applied for only one session by applying light pressure with the thumb of the practitioner's hand, in two directions as the right and left arms, for 2 minutes to each point for a total of 12 minutes. Blood was drawn immediately after the procedure. In order to evaluate the child's pain immediately after the blood collection procedure, the child was asked to mark the most appropriate face on the Wong Baker Faces Pain Rating Scale. In addition, the child's pain was evaluated by the researcher and the parent using the Wong Baker Faces Pain Rating Scale. After the pain assessment, the child's heart rate, oxygen saturation and blood pressure were re-evaluated by the researcher and recorded in the Procedure Record Form.
Placebo (sham) acupressure application is the pressure of the fingers on the non-meridian region without a specific acupressure point. The point used in our research is the point located in the middle of the third and fourth metacarpal bones on the back of the hand. The children in the placebo control group were only touched by the researcher without applying pressure and massage for one minute to the determined placebo point immediately after their physiological parameters were evaluated, and immediately after that, blood collection was performed. Immediately after blood collection, the child was asked to mark the most appropriate facial expression on the Wong Baker Faces Pain Rating Scale so that he or she could evaluate his pain. In addition, the child's pain was evaluated by the researcher and the parent using the Wong Baker Faces Pain Rating Scale. After the pain assessment, the child's heart rate, oxygen saturation and blood pressure were re-evaluated by the researcher and recorded in the Procedure Record Form.
- Conditions
- Pain
- Being tested
- acupressure
- Keywords
- acupressure, thalassemia, child, pediatric nursing
- Medical subject headings
- Pain, Thalassemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
acupressureOther
Before the blood collection procedure, pressure will be applied to the acupressure points determined by the researcher for 2 minutes and then blood collection will be performed.
| Study group | Role | What they receive |
|---|---|---|
| accupressure | Experimental | In the study group (n:19), blood pressure, pulse and oxygen saturation were measured, and the acupressure points determined (large intestine meridian 4. Point: LI 4, large intestine meridian 11. Point: LI 11, Heart Meridian 7. Point: HT 7 ) acupressure was applied for only one session by applying light pressure with the thumb of the practitioner's hand, in two directions as the right and left arms, for 2 minutes to each point for a total of 12 minutes. Blood was drawn immediately after the procedure. In order to evaluate the child's pain immediately after the blood collection procedure, the child was asked to mark the most appropriate face on the Wong Baker Faces Pain Rating Scale. In addition, the child's pain was evaluated by the researcher and the parent using the Wong Baker Faces Pain Rating Scale. After the pain assessment, the child's heart rate, oxygen saturation and blood pressure were re-evaluated by the researcher and recorded in the Procedure Record Form. Receives: Other: acupressure |
| control | Sham comparator | The point used in our research is the point located in the middle of the third and fourth metacarpal bones on the back of the hand. Children in the placebo control group (n:20) were touched by the researcher for one minute without applying pressure or massage to the determined placebo point immediately after their physiological parameters were evaluated. Immediately after blood collection, the child was asked to mark the most appropriate facial expression on the Wong Baker Faces Pain Rating Scale so that he or she could assess his pain. In addition, the child's pain was evaluated by the researcher and the parent using the Wong Baker Faces Pain Rating Scale. Receives: Other: acupressure |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain assessment of the child using the Wong Baker Facial Pain Rating scale
The Wong Baker Facial Pain Rating Scale is rated from 0 to 10 (such as 0-2-4-6-8-10). "0" means no pain, and "10" means the most severe pain. This scale is used to diagnose pain in children ages 3-18.
Measured: Measurements were taken from the scale just before blood was taken.
Wong Baker Faces Pain Rating Scale
It is applied by explaining to the child that each face belongs to a person, that there is a happy face that does not have any pain, and a sad face that feels a little or a lot of pain. The child is asked to choose the face that best expresses his or her feelings by giving an explanation for each face ("0": he is very happy because he has no pain, etc.).
Measured: Measurements were taken just before blood was drawn and a scale was used immediately after blood was drawn.]
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2023
- Study start4 Jun 2022
- Primary completion4 Jun 2022
- Study completion4 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PainStudies of the same condition, open and under way.
- More trials run by Mersin 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
- Model description
- prospective, parallel , randomized controlled clinical trial
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 39 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mersin University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Melek Gulgun Altintas, Mersin University
- Investigators
- MELEK GULGUN ALTINTAS, Phd, Principal investigator, Mersin University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06163196
- Sponsor's protocol ID
- j94ghcf2
- Acronym
- acupressure
- Status last verified
- Dec 2023
- First submitted
- 11 Dec 2022
- Last updated
- 8 Dec 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Study protocol
Study at a glance
From the registry record, last updated by the sponsor on 8 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect Of Acupressure Application On Reducing Pain During Venipuncture İn Children Dıagnosed With Thalassemia.
- ClinicalTrials.gov ID
- NCT06163196
- Acronym / sponsor ID
- acupressure / j94ghcf2
- Conditions
- Pain
- Keywords
- acupressure, thalassemia, child, pediatric nursing
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 39 participants (actual)
- Lead sponsor
- Mersin UniversityUniversity, hospital or other
- Study start
- 4 Jun 2022 (actual)
- Primary completion
- 4 Jun 2022 (actual)
- Study completion
- 4 Jun 2022 (actual)
- First posted
- 8 Dec 2023 (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 randomized controlled trial evaluates the effect of acupressure on reducing the pain of blood collection in children with Thalassemia. The hypothesis of this study is that acupressure application reduces acute pain.
Detailed description
A total of 39 children with a diagnosis of Thalassemia were randomly assigned to the study and control groups. In the study group (n:19), blood pressure, pulse and oxygen saturation were measured, and the acupressure points determined (large intestine meridian 4. Point: LI 4, large intestine meridian 11. Point: LI 11, Heart Meridian 7. Point: HT 7 ) acupressure was applied for only one session by applying light pressure with the thumb of the practitioner's hand, in two directions as the right and left arms, for 2 minutes to each point for a total of 12 minutes. Blood was drawn immediately after the procedure. In order to evaluate the child's pain immediately after the blood collection procedure, the child was asked to mark the most appropriate face on the Wong Baker Faces Pain Rating Scale. In addition, the child's pain was evaluated by the researcher and the parent using the Wong Baker Faces Pain Rating Scale. After the pain assessment, the child's heart rate, oxygen saturation and blood pressure were re-evaluated by the researcher and recorded in the Procedure Record Form.
Placebo (sham) acupressure application is the pressure of the fingers on the non-meridian region without a specific acupressure point. The point used in our research is the point located in the middle of the third and fourth metacarpal bones on the back of the hand. The children in the placebo control group were only touched by the researcher without applying pressure and massage for one minute to the determined placebo point immediately after their physiological parameters were evaluated, and immediately after that, blood collection was performed. Immediately after blood collection, the child was asked to mark the most appropriate facial expression on the Wong Baker Faces Pain Rating Scale so that he or she could evaluate his pain. In addition, the child's pain was evaluated by the researcher and the parent using the Wong Baker Faces Pain Rating Scale. After the pain assessment, the child's heart rate, oxygen saturation and blood pressure were re-evaluated by the researcher and recorded in the Procedure Record Form.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
- Model description
- prospective, parallel , randomized controlled clinical trial
| Arm | Type | Receives |
|---|---|---|
| accupressure | Experimental | Other: acupressureIn the study group (n:19), blood pressure, pulse and oxygen saturation were measured, and the acupressure points determined (large intestine meridian 4. Point: LI 4, large intestine meridian 11. Point: LI 11, Heart Meridian 7. Point: HT 7 ) acupressure was applied for only one session by applying light pressure with the thumb of the practitioner's hand, in two directions as the right and left arms, for 2 minutes to each point for a total of 12 minutes. Blood was drawn immediately after the procedure. In order to evaluate the child's pain immediately after the blood collection procedure, the child was asked to mark the most appropriate face on the Wong Baker Faces Pain Rating Scale. In addition, the child's pain was evaluated by the researcher and the parent using the Wong Baker Faces Pain Rating Scale. After the pain assessment, the child's heart rate, oxygen saturation and blood pressure were re-evaluated by the researcher and recorded in the Procedure Record Form. |
| control | Sham comparator | Other: acupressureThe point used in our research is the point located in the middle of the third and fourth metacarpal bones on the back of the hand. Children in the placebo control group (n:20) were touched by the researcher for one minute without applying pressure or massage to the determined placebo point immediately after their physiological parameters were evaluated. Immediately after blood collection, the child was asked to mark the most appropriate facial expression on the Wong Baker Faces Pain Rating Scale so that he or she could assess his pain. In addition, the child's pain was evaluated by the researcher and the parent using the Wong Baker Faces Pain Rating Scale. |
Who may qualify
- Ages
- 6 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (8 listed)
- Registered in the centers where the study will be carried out,
- Able to communicate verbally
- No developmental or sensory disabilities,
- No mental illness
- No opioid, narcotic analgesic or sedative use in the last 8 hours before the procedure,
Key exclusion criteria (8 listed)
- Having pain before the blood draw procedure,
- Not between the ages of 6-18,
- Have developmental or sensory disabilities,
- Having a mental illness
- Using opioids, narcotic analgesics or sedatives in the last 8 hours before the procedure,
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 |
|---|---|---|
| acupressureBefore the blood collection procedure, pressure will be applied to the acupressure points determined by the researcher for 2 minutes and then blood collection will be performed. | Other | accupressure, control |
Primary outcome
Pain assessment of the child using the Wong Baker Facial Pain Rating scale
Time frame: Measurements were taken from the scale just before blood was taken.
The Wong Baker Facial Pain Rating Scale is rated from 0 to 10 (such as 0-2-4-6-8-10). "0" means no pain, and "10" means the most severe pain. This scale is used to diagnose pain in children ages 3-18.
Wong Baker Faces Pain Rating Scale
Time frame: Measurements were taken just before blood was drawn and a scale was used immediately after blood was drawn.]
It is applied by explaining to the child that each face belongs to a person, that there is a happy face that does not have any pain, and a sad face that feels a little or a lot of pain. The child is asked to choose the face that best expresses his or her feelings by giving an explanation for each face ("0": he is very happy because he has no pain, etc.).
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 Dec 2023.
- Individual participant dataSharing planned: No. Study protocol
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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.
MELEK GULGUN ALTINTAS, Phd principal investigator
Mersin 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 acupressure in people with Pain, run by Mersin 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 8 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 Dec 2023. 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. Some participants in this study may receive a placebo. 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 assessment of the child using the Wong Baker Facial Pain Rating scale (time frame: Measurements were taken from the scale just before blood was taken.). 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 8 Dec 2023.