Pain, AcuteNCT06231719
Efficacy of Manuel Pressure and Local Cold Spray in Reducing Injection Pain in Pregnant Women
A study testing Cold Spray, Manuel Pressure and Standard Injection Procedure in people with Pain, Acute and Alloimmunisation in Pregnancy, run by Gulsum Coskun at 1 site in Turkey (Türkiye).
Trial summary
A randomized controlled study was planned to determine the effect of manual pressure and local cold spray application on the intensity of pain, fear, hemodynamic parameters, and satisfaction related to the pain reduction of human Anti-D immunoglobulin injection administered to pregnant women. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pain, Acute, Alloimmunisation in Pregnancy, Injection Site
- What is being tested?
- Cold Spray, Manuel Pressure and Standard Injection Procedure
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 129 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Dec 2023to 30 Jul 2024
- 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 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Ability to understand, speak, read and understand Turkish
- Volunteering to participate in the study
- Being pregnant (gestational week 20 and above)
- Being between the ages of 18-45
- Has not had an IM injection in the last week
- There are no complications related to IM injections such as pain, abscess, infection, tissue necrosis, hematoma at the IM injection site.
Show all 9Show fewer
- Not taking any analgesics before the procedure
- No chronic disease
- Those who do not have visual or cognitive impairments that prevent them from marking measurement tools
Who cannot join
- Not volunteering to participate in the study
- Having chronic pain disorders
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Kartal Dr. Lütfi Kırdar City Hospital
Istanbul
About this study
Official title: Evaluation of the Efficacy of Manual Pressure and Local Cold Spray Application in Reducing Pain Caused by Human Anti-D Immunoglobulin Injection in Pregnant Women: A Randomized Controlled Study
A randomized controlled study was planned to determine the effect of manual pressure and local cold spray application on the intensity of pain, fear, hemodynamic parameters, and satisfaction related to the pain reduction of human Anti-D immunoglobulin injection administered to pregnant women.
Read the detailed description
Injections are a commonly used treatment method that can induce fear, tension and anxiety in individuals despite their frequent use. The use of long needles, especially for intramuscular injections, to reach the target area through an injection can disrupt tissue integrity and cause discomfort. Therefore, injection pain is a widespread problem. Depending on the severity of perceived pain, it can affect an individual's hemodynamic parameters. Pain-related factors such as high heart rate, blood pressure, low oxygen saturation, and hyperventilation can develop. Primary caregivers, such as nurses, attempt to minimize pain by using pharmacological methods (local anesthesia, adjuvant analgesia, non-steroidal anti-inflammatory drugs (NSAID), opioids, paracetamol) and non-pharmacological interventions (manual pressure, cold application, Helfer skin tap, Shotblocker, massage, internal rotation, Buzzy). Human Anti-D immunoglobulin injection, like all other injections, causes pain, negatively affecting the quality of life and treatment experiences of individuals. In our study, we aim to evaluate the effectiveness of pre-injection manual pressure and local cold spray application, create data in the clinical field and reduce injection pain in pregnant women to have a positive impact on injection satisfaction and hemodynamic parameters.
- Being tested
- Cold Spray, Manuel Pressure, Standard Injection Procedure
- Keywords
- Human Anti-D Immunglobulin, Red Blood Cell, Alloimmunization, Injection Pain, Local Cold Therapy, Manuel Pressure, Pregnancy
- Medical subject headings
- Acute Pain, Iatrophobia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cold SprayOther
Using cold spray for injection site before the Anti-D immunglobulin injection. 2 sprays of cold spray are applied from a distance of 25 cm.
Manuel PressureOther
Using manuel pressure ( about 10 second ) before the Anti-D immunglobulin injection.
Standard Injection ProcedureOther
Using any special method for injection
| Study group | Role | What they receive |
|---|---|---|
| Anti-D Immunglobulin Injection with Cold Spray | Experimental | Using cold spray before the Anti-D immunoglobulin injection Receives: Other: Cold Spray |
| Anti-D Immunglobulin Injection with Manuel Pressure | Experimental | Apply Manuel pressure before the Anti-D immunoglobulin injection Receives: Other: Manuel Pressure |
| Standard Anti-D Immunoglobulin Injection | Placebo comparator | Standard procedure for Anti-D immunglobulin injection Receives: Other: Standard Injection Procedure |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain Intensity
Visual Analog Scale will be used to measure the injection pain intensity in pregnant women receiving the Human Immunoglobulin Anti-D injection. Participants in the study will be asked to mark their own pain level on a 10 cm ruler with "no pain" at one end and "unbearable pain" at the other. The preference for using VAS in pain intensity measurement is due to its ability to provide a numerical and replicable measurement according to the purpose.
Measured: Approximately 3 minute after injection
Injection Satisfaction
When reviewing the literature, no specific scale for assessing satisfaction with IM injection applications was found. Upon examining national and international studies assessing satisfaction with IM injection, it was determined that VAS was utilized.In order to assess the satisfaction of patients after the injection, a scale with a vertical line of 10 cm, with "Very Satisfied" at one end and "Not Satisfied at All" at the other end, will be used. The selection of this scale is primarily influenced by its similarity to VAS and its ease of understanding and marking. The use of a vertical dimension is deemed appropriate for better clarity.
Measured: Approximately 4 minute after injection
Pain Fear
The Pain Fear Scale III was developed by McNeil and Rainwater to measure fear and/or anxiety related to pain. Ünver and Turan conducted a Turkish validity and reliability study for the scale. The scale consists of three subscales, each with 10 items. The subscales and their respective items are listed. In evaluating the scale without reverse scoring, items are rated on a Likert-type scale ranging from 1 to 5 (1-Never, 2-Slightly, 3-Fairly, 4-Very, 5-Extremely). The minimum total score is 30, and the maximum total score is 150. For each subscale, the minimum score is 10, and the maximum score is 50. A higher score on the scale indicates higher pain fear.
Measured: Before injection
Introductory Information Form
The form prepared by the researcher, based on literature information, consists of a total of 10 questions related to the socio-demographic characteristics (age, height, weight, employment status, education level, job, blood type) and obstetric characteristics (last menstrual period, gravida , miscarriage, abortion, parity, type of delivery and previous use of Human Immunoglobulin Anti-D injection) of pregnant women prescribed with Human Immunoglobulin Anti-D injection. The same form will be used for recording the hemodynamic parameters (pulse rate, blood pressure, respiratory rate, and oxygen saturation) of pregnant women before and after the injection, which will be measured by the researcher.
Measured: After participants agree to participate in the research and sign the informed consent form, this form is filled out by the researchers.All of these take approximately 15 minutes.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2024
- Study start1 Dec 2023
- Primary completion1 Jul 2024 (estimated)
- Study completion30 Jul 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pain, AcuteStudies 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
- Sequential
- Model description
- Two intervention ,one control group
- Masking
- None (open label)
- Enrolment
- 129 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gulsum Coskun
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Gulsum Coskun, Marmara University
- Investigators
- Dilek Coşkuner Potur, A. Professor, Study director, Supervisor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06231719
- Sponsor's protocol ID
- Kartalsehir
- Status last verified
- Jun 2024
- First submitted
- 30 Nov 2023
- Last updated
- 5 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Coskun UG, Coskuner Potur D. Evaluation of the efficacy of manual pressure and local cold spray application in reducing pain caused by human anti-D immunoglobulin injection in pregnant women: a randomized controlled study. BMC Pregnancy Childbirth. 2026 Mar 24;26(1):479. doi: 10.1186/s12884-026-08977-7.
PubMed 41872825
Study at a glance
From the registry record, last updated by the sponsor on 5 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Efficacy of Manual Pressure and Local Cold Spray Application in Reducing Pain Caused by Human Anti-D Immunoglobulin Injection in Pregnant Women: A Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT06231719
- Acronym / sponsor ID
- Kartalsehir
- Keywords
- Human Anti-D Immunglobulin, Red Blood Cell, Alloimmunization, Injection Pain, Local Cold Therapy, Manuel Pressure, Pregnancy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 129 participants (actual)
- Lead sponsor
- Gulsum CoskunUniversity, hospital or other
- Study start
- 1 Dec 2023 (actual)
- Primary completion
- 1 Jul 2024 (estimated)
- Study completion
- 30 Jul 2024 (estimated)
- First posted
- 30 Jan 2024 (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.
A randomized controlled study was planned to determine the effect of manual pressure and local cold spray application on the intensity of pain, fear, hemodynamic parameters, and satisfaction related to the pain reduction of human Anti-D immunoglobulin injection administered to pregnant women.
Detailed description
Injections are a commonly used treatment method that can induce fear, tension and anxiety in individuals despite their frequent use. The use of long needles, especially for intramuscular injections, to reach the target area through an injection can disrupt tissue integrity and cause discomfort. Therefore, injection pain is a widespread problem. Depending on the severity of perceived pain, it can affect an individual's hemodynamic parameters. Pain-related factors such as high heart rate, blood pressure, low oxygen saturation, and hyperventilation can develop. Primary caregivers, such as nurses, attempt to minimize pain by using pharmacological methods (local anesthesia, adjuvant analgesia, non-steroidal anti-inflammatory drugs (NSAID), opioids, paracetamol) and non-pharmacological interventions (manual pressure, cold application, Helfer skin tap, Shotblocker, massage, internal rotation, Buzzy). Human Anti-D immunoglobulin injection, like all other injections, causes pain, negatively affecting the quality of life and treatment experiences of individuals. In our study, we aim to evaluate the effectiveness of pre-injection manual pressure and local cold spray application, create data in the clinical field and reduce injection pain in pregnant women to have a positive impact on injection satisfaction and hemodynamic parameters.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Two intervention ,one control group
| Arm | Type | Receives |
|---|---|---|
| Anti-D Immunglobulin Injection with Cold Spray | Experimental | Other: Cold SprayUsing cold spray before the Anti-D immunoglobulin injection |
| Anti-D Immunglobulin Injection with Manuel Pressure | Experimental | Other: Manuel PressureApply Manuel pressure before the Anti-D immunoglobulin injection |
| Standard Anti-D Immunoglobulin Injection | Placebo comparator | Other: Standard Injection ProcedureStandard procedure for Anti-D immunglobulin injection |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- Ability to understand, speak, read and understand Turkish
- Volunteering to participate in the study
- Being pregnant (gestational week 20 and above)
- Being between the ages of 18-45
- Has not had an IM injection in the last week
Key exclusion criteria (2 listed)
- Not volunteering to participate in the study
- Having chronic pain disorders
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 |
|---|---|---|
| Cold SprayUsing cold spray for injection site before the Anti-D immunglobulin injection. 2 sprays of cold spray are applied from a distance of 25 cm. | Other | Anti-D Immunglobulin Injection with Cold Spray |
| Manuel PressureUsing manuel pressure ( about 10 second ) before the Anti-D immunglobulin injection. | Other | Anti-D Immunglobulin Injection with Manuel Pressure |
| Standard Injection ProcedureUsing any special method for injection | Other | Standard Anti-D Immunoglobulin Injection |
Primary outcome
Pain Intensity
Time frame: Approximately 3 minute after injection
Visual Analog Scale will be used to measure the injection pain intensity in pregnant women receiving the Human Immunoglobulin Anti-D injection. Participants in the study will be asked to mark their own pain level on a 10 cm ruler with "no pain" at one end and "unbearable pain" at the other. The preference for using VAS in pain intensity measurement is due to its ability to provide a numerical and replicable measurement according to the purpose.
Injection Satisfaction
Time frame: Approximately 4 minute after injection
When reviewing the literature, no specific scale for assessing satisfaction with IM injection applications was found. Upon examining national and international studies assessing satisfaction with IM injection, it was determined that VAS was utilized.In order to assess the satisfaction of patients after the injection, a scale with a vertical line of 10 cm, with "Very Satisfied" at one end and "Not Satisfied at All" at the other end, will be used. The selection of this scale is primarily influenced by its similarity to VAS and its ease of understanding and marking. The use of a vertical dimension is deemed appropriate for better clarity.
Pain Fear
Time frame: Before injection
The Pain Fear Scale III was developed by McNeil and Rainwater to measure fear and/or anxiety related to pain. Ünver and Turan conducted a Turkish validity and reliability study for the scale. The scale consists of three subscales, each with 10 items. The subscales and their respective items are listed. In evaluating the scale without reverse scoring, items are rated on a Likert-type scale ranging from 1 to 5 (1-Never, 2-Slightly, 3-Fairly, 4-Very, 5-Extremely). The minimum total score is 30, and the maximum total score is 150. For each subscale, the minimum score is 10, and the maximum score is 50. A higher score on the scale indicates higher pain fear.
Introductory Information Form
Time frame: After participants agree to participate in the research and sign the informed consent form, this form is filled out by the researchers.All of these take approximately 15 minutes.
The form prepared by the researcher, based on literature information, consists of a total of 10 questions related to the socio-demographic characteristics (age, height, weight, employment status, education level, job, blood type) and obstetric characteristics (last menstrual period, gravida , miscarriage, abortion, parity, type of delivery and previous use of Human Immunoglobulin Anti-D injection) of pregnant women prescribed with Human Immunoglobulin Anti-D injection. The same form will be used for recording the hemodynamic parameters (pulse rate, blood pressure, respiratory rate, and oxygen saturation) of pregnant women before and after the injection, which will be measured by the researcher.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jun 2024.
- Derived from this study: PubMed 41872825Coskun UG, Coskuner Potur D. Evaluation of the efficacy of manual pressure and local cold spray application in reducing pain caused by human anti-D immunoglobulin injection in pregnant women: a randomized controlled study. BMC Pregnancy Childbirth. 2026 Mar 24;26(1):479. doi: 10.1186/s12884-026-08977-7.
- Detailed Information About InjectionLink provided by the sponsor.
- 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.
Dilek Coşkuner Potur, A. Professor study director
Supervisor
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cold Spray, Manuel Pressure and Standard Injection Procedure in people with Pain, Acute and Alloimmunisation in Pregnancy, run by Gulsum Coskun 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 9 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 5 Jun 2024. 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?
Results are not available in the source record.
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 Intensity (time frame: Approximately 3 minute after injection). The study lists 4 primary outcomes in all. 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 NCT06231719, which also lists 1 linked publication.
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 5 Jun 2024.