Acute PainNCT03553901
The Effect of Acupressure (GB30) on Ventrogluteal Intramuscular Injection Pain
A study testing Acupressure in people with Acute Pain and Injection, run by Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey.
Trial summary
Acupressure is an ancient manual therapy which fingers are used to press key points on the body. These points are the same with acupuncture points but in contrast to acupuncture, acupressure uses gentle but firm pressure with fingers and hands. Read more about this study
- Who is it for?
- Ages 18 to 25 yearsHealthy volunteers can take part
- Conditions the study is for
- Acute Pain, Injection, Needle Phobia
- What is being tested?
- Acupressure
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2016to 1 Aug 2017
- 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 18 to 25 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Body Mass Index (BMI) of 18.5 to 29.9kg/m2
- Voluntariness
Who cannot join
- history of IM injection within 2 weeks
About this study
Official title: The Effect of Acupressure (GB30) on Ventrogluteal Intramuscular Injection Pain - A Crossover Randomized Single-blind Study
Acupressure is an ancient manual therapy which fingers are used to press key points on the body. These points are the same with acupuncture points but in contrast to acupuncture, acupressure uses gentle but firm pressure with fingers and hands. The purpose of this study is to investigate effect of acupressure onto GB30 poin for ventrogluteal intramuscular injection pain.The study was designed as a prospective, single-blind, crossover study. The study included 72 volunteer students attending Faculty of Health Sciences, Nursing Department.
- Conditions
- Acute Pain, Injection, Needle Phobia
- Being tested
- Acupressure
- Medical subject headings
- Acute Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AcupressureProcedure or surgery
Acupressure was performed before the injection onto GB30 point
| Study group | Role | What they receive |
|---|---|---|
| Acupressure | Experimental | Acupressure is applied before injection Receives: Procedure: Acupressure |
| Control group | No intervention | acupressure is not applied before injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of pain during intramuscular injection with 10 cm VAS (Visual Analog Scale)
Assessment of pain during intramuscular injection will be marked on 10 cm VAS scale 0-10 ( 0:no pain 10:Worst possible pain ) by the patient and will be measured
Measured: 2 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2018
- Study start1 Sep 2016
- Primary completion1 Jun 2017
- Study completion1 Aug 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Gökhan inangil, Study director, Sultan Abdulhamid Han
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03553901
- Sponsor's protocol ID
- Sultan Abdulhamid
- Status last verified
- Jun 2018
- First submitted
- 30 May 2018
- Last updated
- 13 Jun 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Suhrabi Z, Taghinejad H. Effect of acupressure (UB32) on pain intensity in intramuscular injections. Iran J Nurs Midwifery Res. 2014 Jan;19(1):24-7.
PubMed 24554956Hosseinabadi R, Biranvand S, Pournia Y, Anbari K. The Effect of Acupressure on Pain and Anxiety Caused by Venipuncture. J Infus Nurs. 2015 Nov-Dec;38(6):397-405. doi: 10.1097/NAN.0000000000000065.
PubMed 26536327Chung JW, Ng WM, Wong TK. An experimental study on the use of manual pressure to reduce pain in intramuscular injections. J Clin Nurs. 2002 Jul;11(4):457-61. doi: 10.1046/j.1365-2702.2002.00645.x.
PubMed 12100641
Study at a glance
From the registry record, last updated by the sponsor on 13 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Acupressure (GB30) on Ventrogluteal Intramuscular Injection Pain - A Crossover Randomized Single-blind Study
- ClinicalTrials.gov ID
- NCT03553901
- Acronym / sponsor ID
- Sultan Abdulhamid
- Conditions
- Acute Pain, Injection, Needle Phobia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- Sultan Abdulhamid Han Training and Research Hospital, Istanbul, TurkeyUniversity, hospital or other
- Study start
- 1 Sep 2016 (actual)
- Primary completion
- 1 Jun 2017 (actual)
- Study completion
- 1 Aug 2017 (actual)
- First posted
- 12 Jun 2018 (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.
Acupressure is an ancient manual therapy which fingers are used to press key points on the body. These points are the same with acupuncture points but in contrast to acupuncture, acupressure uses gentle but firm pressure with fingers and hands. The purpose of this study is to investigate effect of acupressure onto GB30 poin for ventrogluteal intramuscular injection pain.The study was designed as a prospective, single-blind, crossover study. The study included 72 volunteer students attending Faculty of Health Sciences, Nursing Department.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Acupressure | Experimental | Procedure: AcupressureAcupressure is applied before injection |
| Control group | No intervention | –acupressure is not applied before injection |
Who may qualify
- Ages
- 18 to 25 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Body Mass Index (BMI) of 18.5 to 29.9kg/m2
- Voluntariness
Key exclusion criteria (1 listed)
- history of IM injection within 2 weeks
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 |
|---|---|---|
| AcupressureAcupressure was performed before the injection onto GB30 point | Procedure or surgery | Acupressure |
Primary outcome
Assessment of pain during intramuscular injection with 10 cm VAS (Visual Analog Scale)
Time frame: 2 minutes
Assessment of pain during intramuscular injection will be marked on 10 cm VAS scale 0-10 ( 0:no pain 10:Worst possible pain ) by the patient and will be measured
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 Jun 2018.
- Background: PubMed 24554956Suhrabi Z, Taghinejad H. Effect of acupressure (UB32) on pain intensity in intramuscular injections. Iran J Nurs Midwifery Res. 2014 Jan;19(1):24-7.
- Background: PubMed 26536327Hosseinabadi R, Biranvand S, Pournia Y, Anbari K. The Effect of Acupressure on Pain and Anxiety Caused by Venipuncture. J Infus Nurs. 2015 Nov-Dec;38(6):397-405. doi: 10.1097/NAN.0000000000000065.
- Background: PubMed 12100641Chung JW, Ng WM, Wong TK. An experimental study on the use of manual pressure to reduce pain in intramuscular injections. J Clin Nurs. 2002 Jul;11(4):457-61. doi: 10.1046/j.1365-2702.2002.00645.x.
- 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.
Gökhan inangil study director
Sultan Abdulhamid Han
Questions about this trial
What is this clinical trial studying?
A study testing Acupressure in people with Acute Pain and Injection, run by Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey.
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 2 inclusion and 1 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 Jun 2018. Status can change between updates, so confirm with the study contact before making plans.
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?
Assessment of pain during intramuscular injection with 10 cm VAS (Visual Analog Scale) (time frame: 2 minutes). 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 NCT03553901, which also lists 3 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 13 Jun 2018.