Ignite Creation Date:
2025-12-25 @ 1:39 AM
Ignite Modification Date:
2025-12-25 @ 11:55 PM
Study NCT ID:
NCT07233694
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-11-18
First Post:
2025-06-14
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
IM İnjection-PAIN-Cold Spray and Stress Ball
Sponsor:
Erzincan Binali Yildirim Universitesi
Organization:
Study Overview
Official Title:
The Effects of Cold Spray and Stress Ball Methods on Perceived Pain, Comfort, and Satisfaction During Intramuscular Injection: A Randomized Controlled Trial
Status:
NOT_YET_RECRUITING
Status Verified Date:
2025-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
CSB-PAIN
Brief Summary:
Brief Summary:
Intramuscular (IM) injection is a widely used method for drug administration, with over 12 billion applications globally each year. Despite its therapeutic advantages, IM injection often causes pain, which can negatively impact patient comfort and lead to injection fear, non-compliance, and avoidance of healthcare services. Effective pain management during IM injection is an ethical and professional responsibility for nurses. This randomized controlled study aims to compare the effectiveness of cold spray and stress ball squeezing methods against standard practice in reducing IM injection-related pain. The study will be conducted in the emergency department of a university hospital in Turkey between March and June 2025, involving 66 patients prescribed IM diclofenac sodium. Participants will be randomly assigned to one of three groups: cold spray, stress ball, or control. Pain will be assessed using the Visual Analog Scale (VAS) within the first minute after injection.
Intramuscular (IM) injection is a widely used method for drug administration, with over 12 billion applications globally each year. Despite its therapeutic advantages, IM injection often causes pain, which can negatively impact patient comfort and lead to injection fear, non-compliance, and avoidance of healthcare services. Effective pain management during IM injection is an ethical and professional responsibility for nurses. This randomized controlled study aims to compare the effectiveness of cold spray and stress ball squeezing methods against standard practice in reducing IM injection-related pain. The study will be conducted in the emergency department of a university hospital in Turkey between March and June 2025, involving 66 patients prescribed IM diclofenac sodium. Participants will be randomly assigned to one of three groups: cold spray, stress ball, or control. Pain will be assessed using the Visual Analog Scale (VAS) within the first minute after injection.
Detailed Description:
Study Description
Brief Summary:
Intramuscular (IM) injection is a widely used method for drug administration, with over 12 billion applications globally each year. Despite its therapeutic advantages, IM injection often causes pain, which can negatively impact patient comfort and lead to injection fear, non-compliance, and avoidance of healthcare services. Effective pain management during IM injection is an ethical and professional responsibility for nurses. This randomized controlled study aims to compare the effectiveness of cold spray and stress ball squeezing methods against standard practice in reducing IM injection-related pain. The study will be conducted in the emergency department of a university hospital in Turkey between March and June 2025, involving 66 patients prescribed IM diclofenac sodium. Participants will be randomly assigned to one of three groups: cold spray, stress ball, or control. Pain will be assessed using the Visual Analog Scale (VAS) within the first minute after injection.
Detailed Description:
Intramuscular (IM) injection is a fundamental method for delivering drugs directly into muscle tissue for systemic circulation. It is one of the most common invasive procedures in clinical practice globally, with over 12 billion applications annually. While offering faster absorption and higher bioavailability compared to oral and other parenteral routes for various pharmacological agents like vaccines, analgesics, sedatives, and antibiotics, IM injection can cause pain during administration, affecting patient comfort. This pain is a frequently reported side effect and can lead to injection phobia, non-adherence to treatment, and avoidance of health services. Consequently, managing pain during IM injections is a crucial ethical and professional responsibility for nurses.
Various non-pharmacological methods have been developed in nursing practice to reduce IM injection pain, and their efficacy has been extensively evaluated. These interventions include ShotBlocker, manual pressure, acupuncture, air-lock, distraction, and cold application. Cold application is a commonly preferred method for acute pain management due to its non-pharmacological effect and ease of clinical application. Cold sprays, in particular, offer significant advantages in clinical practice due to their minimal preparation, rapid effect, and low cost. These medical agents, derived from liquefied gases, rapidly evaporate from the skin surface, reducing local temperature and providing temporary superficial anesthesia. Their analgesic effects are achieved by inhibiting the activation of ion channels involved in pain transmission or by reducing the sensitivity of pain receptors. Limited studies have investigated cold spray use for IM injection pain control in adults. Comparative studies with ShotBlocker have reported that cold spray significantly reduces pain, but no significant difference was found between the two methods.
Distraction methods are effective nursing approaches that aim to reduce pain perception by shifting cognitive focus away from painful stimuli. The stress ball squeezing method, used within this strategy, has been applied in various invasive procedures and found effective in pain control. However, only one study has specifically evaluated its effect on IM injection pain. This study, conducted during Pfizer-BioNTech COVID-19 vaccination, reported no statistically significant effect of stress ball squeezing on pain levels.
Despite numerous studies on IM injection-related pain, it remains a prevalent clinical issue. Cold spray and stress ball squeezing offer practical options for pain reduction. However, studies evaluating their direct effects on IM injection pain are limited, and no direct comparative studies exist. Addressing this gap is crucial for evidence-based nursing care and improving patient experience.
This study aims to develop effective and applicable strategies to enhance care quality by comparatively evaluating cold spray, stress ball, and standard practice for reducing IM injection-related pain. Specifically, it aims to compare the effects of cold spray and stress ball squeezing methods on injection pain during IM injection and to examine their effectiveness in reducing pain compared to standard practice.
The research hypotheses are:
H1. The application of cold spray to the injection site during IM injection reduces the intensity of pain caused by the injection.
H2. Squeezing a stress ball during IM injection reduces the intensity of pain caused by the injection.
H3. Cold spray application is more effective than stress ball squeezing in reducing injection pain.
Study Design and Participants:
This study is a three-arm parallel-group, single-blind, randomized controlled experimental design, conducted in accordance with the CONSORT 2010 guidelines. The research will be conducted from March to June 2025 in the emergency department of a university hospital in Turkey. The sample will consist of 66 patients who present to the emergency department and have been prescribed IM diclofenac sodium. The sample size was calculated using G Power 3.1.9.7, based on variance values from a relevant article, with a 95% confidence interval, 0.05 error rate, 80% power, and an effect size of d=0.63, determining 22 participants per group.
Randomization and Allocation Concealment:
Participants will be randomly assigned to the cold spray, stress ball, or control group using a random number table generated via
https://www.random.org. Numbers from 1 to 66 will be written on separate slips of paper, placed in opaque envelopes, and sealed. Each eligible participant who consents to the study will select an envelope, and the number drawn will determine their group assignment.
Data Collection Instruments:
Data will be collected using a Patient Identification Form and a Visual Analog Scale (VAS). The Patient Identification Form will gather sociodemographic and clinical information such as age, gender, marital status, education level, body mass index, and chronic health conditions. The VAS is a valid and reliable 10-centimeter linear scale used to assess pain intensity, ranging from "no pain at all" (0) to "unbearable pain" (10). It is widely used in clinical studies due to its ease of application and effectiveness in evaluating pain reduction methods.
Intervention Materials:
Cold Spray: Galena® brand, aerosol form, containing butane, propane, and isobutane, which rapidly evaporates to reduce skin temperature and provide temporary superficial anesthesia.
Stress Ball: Approximately 10 cm in diameter, medium firmness, made of high-quality silicone, designed to change shape when squeezed and return to its original form.
Data Collection Process:
Before data collection, eligible patients will be informed about the study's purpose and content, and written and verbal consent will be obtained. All participants will complete the "Patient Identification Form" before the intervention. All IM injections will be administered by the same researcher following a standardized protocol to minimize variability. The injection side (right or left ventrogluteal region) will be randomly determined for each participant. Pain assessment will be performed within the first minute after injection by an independent nurse blinded to the patient's group, using the VAS.
Standard Intramuscular Injection Protocol:
Drug: Diclofenac sodium (3 mL)
Needle size: 21 Gauge
Syringe volume: 5 mL
Injection site: Left or right ventrogluteal region
Skin cleansing: The injection site will be cleaned with an alcohol swab in a 5 cm diameter, using circular movements from inside to outside, and 5 seconds will be waited for the area to dry before needle insertion.
Air-lock: 0.2-0.3 mL
Insertion angle: 90∘
Aspiration: Yes (5 sec)
Drug injection duration: 30 sec (1 mL / 10 sec)
Waiting time before needle removal: 10 sec
Post-injection application: Light pressure will be applied to the area for 15-20 seconds.
Pain measurement: Pain level will be assessed with VAS within the first 1 minute after injection and recorded.
Intervention Groups:
Cold Spray Group: Before the injection, cold spray will be applied for 5 seconds from a distance of 15 cm to an approximately 10cm 2 area at the planned injection site. The IM injection will then be performed within 15 seconds, following the standard protocol.
Stress Ball Group: Participants will be instructed on how to use the stress ball. After the injection site is randomly determined, a medium-firm stress ball will be given to the participant's non-injection hand, and they will be asked to rhythmically squeeze and release it throughout the procedure. The injection will be performed according to the standard protocol.
Control Group: Participants in this group will receive only the standard IM injection protocol without any additional interventions.
Ethical Considerations:
Ethical approval was obtained from Gümüşhane University Scientific Research and Publication Ethics Committee (2024, E-95674917-108.99-291198) and written application permission from Van Provincial Health Directorate before data collection. Informed written and verbal consent will be obtained from all participants after explaining the study's purpose and content. Principles of informed consent, respect for participant autonomy, and confidentiality of personal information will be maintained during data collection. All participants will be informed of their right to withdraw from the study at any time.
Brief Summary:
Intramuscular (IM) injection is a widely used method for drug administration, with over 12 billion applications globally each year. Despite its therapeutic advantages, IM injection often causes pain, which can negatively impact patient comfort and lead to injection fear, non-compliance, and avoidance of healthcare services. Effective pain management during IM injection is an ethical and professional responsibility for nurses. This randomized controlled study aims to compare the effectiveness of cold spray and stress ball squeezing methods against standard practice in reducing IM injection-related pain. The study will be conducted in the emergency department of a university hospital in Turkey between March and June 2025, involving 66 patients prescribed IM diclofenac sodium. Participants will be randomly assigned to one of three groups: cold spray, stress ball, or control. Pain will be assessed using the Visual Analog Scale (VAS) within the first minute after injection.
Detailed Description:
Intramuscular (IM) injection is a fundamental method for delivering drugs directly into muscle tissue for systemic circulation. It is one of the most common invasive procedures in clinical practice globally, with over 12 billion applications annually. While offering faster absorption and higher bioavailability compared to oral and other parenteral routes for various pharmacological agents like vaccines, analgesics, sedatives, and antibiotics, IM injection can cause pain during administration, affecting patient comfort. This pain is a frequently reported side effect and can lead to injection phobia, non-adherence to treatment, and avoidance of health services. Consequently, managing pain during IM injections is a crucial ethical and professional responsibility for nurses.
Various non-pharmacological methods have been developed in nursing practice to reduce IM injection pain, and their efficacy has been extensively evaluated. These interventions include ShotBlocker, manual pressure, acupuncture, air-lock, distraction, and cold application. Cold application is a commonly preferred method for acute pain management due to its non-pharmacological effect and ease of clinical application. Cold sprays, in particular, offer significant advantages in clinical practice due to their minimal preparation, rapid effect, and low cost. These medical agents, derived from liquefied gases, rapidly evaporate from the skin surface, reducing local temperature and providing temporary superficial anesthesia. Their analgesic effects are achieved by inhibiting the activation of ion channels involved in pain transmission or by reducing the sensitivity of pain receptors. Limited studies have investigated cold spray use for IM injection pain control in adults. Comparative studies with ShotBlocker have reported that cold spray significantly reduces pain, but no significant difference was found between the two methods.
Distraction methods are effective nursing approaches that aim to reduce pain perception by shifting cognitive focus away from painful stimuli. The stress ball squeezing method, used within this strategy, has been applied in various invasive procedures and found effective in pain control. However, only one study has specifically evaluated its effect on IM injection pain. This study, conducted during Pfizer-BioNTech COVID-19 vaccination, reported no statistically significant effect of stress ball squeezing on pain levels.
Despite numerous studies on IM injection-related pain, it remains a prevalent clinical issue. Cold spray and stress ball squeezing offer practical options for pain reduction. However, studies evaluating their direct effects on IM injection pain are limited, and no direct comparative studies exist. Addressing this gap is crucial for evidence-based nursing care and improving patient experience.
This study aims to develop effective and applicable strategies to enhance care quality by comparatively evaluating cold spray, stress ball, and standard practice for reducing IM injection-related pain. Specifically, it aims to compare the effects of cold spray and stress ball squeezing methods on injection pain during IM injection and to examine their effectiveness in reducing pain compared to standard practice.
The research hypotheses are:
H1. The application of cold spray to the injection site during IM injection reduces the intensity of pain caused by the injection.
H2. Squeezing a stress ball during IM injection reduces the intensity of pain caused by the injection.
H3. Cold spray application is more effective than stress ball squeezing in reducing injection pain.
Study Design and Participants:
This study is a three-arm parallel-group, single-blind, randomized controlled experimental design, conducted in accordance with the CONSORT 2010 guidelines. The research will be conducted from March to June 2025 in the emergency department of a university hospital in Turkey. The sample will consist of 66 patients who present to the emergency department and have been prescribed IM diclofenac sodium. The sample size was calculated using G Power 3.1.9.7, based on variance values from a relevant article, with a 95% confidence interval, 0.05 error rate, 80% power, and an effect size of d=0.63, determining 22 participants per group.
Randomization and Allocation Concealment:
Participants will be randomly assigned to the cold spray, stress ball, or control group using a random number table generated via
https://www.random.org. Numbers from 1 to 66 will be written on separate slips of paper, placed in opaque envelopes, and sealed. Each eligible participant who consents to the study will select an envelope, and the number drawn will determine their group assignment.
Data Collection Instruments:
Data will be collected using a Patient Identification Form and a Visual Analog Scale (VAS). The Patient Identification Form will gather sociodemographic and clinical information such as age, gender, marital status, education level, body mass index, and chronic health conditions. The VAS is a valid and reliable 10-centimeter linear scale used to assess pain intensity, ranging from "no pain at all" (0) to "unbearable pain" (10). It is widely used in clinical studies due to its ease of application and effectiveness in evaluating pain reduction methods.
Intervention Materials:
Cold Spray: Galena® brand, aerosol form, containing butane, propane, and isobutane, which rapidly evaporates to reduce skin temperature and provide temporary superficial anesthesia.
Stress Ball: Approximately 10 cm in diameter, medium firmness, made of high-quality silicone, designed to change shape when squeezed and return to its original form.
Data Collection Process:
Before data collection, eligible patients will be informed about the study's purpose and content, and written and verbal consent will be obtained. All participants will complete the "Patient Identification Form" before the intervention. All IM injections will be administered by the same researcher following a standardized protocol to minimize variability. The injection side (right or left ventrogluteal region) will be randomly determined for each participant. Pain assessment will be performed within the first minute after injection by an independent nurse blinded to the patient's group, using the VAS.
Standard Intramuscular Injection Protocol:
Drug: Diclofenac sodium (3 mL)
Needle size: 21 Gauge
Syringe volume: 5 mL
Injection site: Left or right ventrogluteal region
Skin cleansing: The injection site will be cleaned with an alcohol swab in a 5 cm diameter, using circular movements from inside to outside, and 5 seconds will be waited for the area to dry before needle insertion.
Air-lock: 0.2-0.3 mL
Insertion angle: 90∘
Aspiration: Yes (5 sec)
Drug injection duration: 30 sec (1 mL / 10 sec)
Waiting time before needle removal: 10 sec
Post-injection application: Light pressure will be applied to the area for 15-20 seconds.
Pain measurement: Pain level will be assessed with VAS within the first 1 minute after injection and recorded.
Intervention Groups:
Cold Spray Group: Before the injection, cold spray will be applied for 5 seconds from a distance of 15 cm to an approximately 10cm 2 area at the planned injection site. The IM injection will then be performed within 15 seconds, following the standard protocol.
Stress Ball Group: Participants will be instructed on how to use the stress ball. After the injection site is randomly determined, a medium-firm stress ball will be given to the participant's non-injection hand, and they will be asked to rhythmically squeeze and release it throughout the procedure. The injection will be performed according to the standard protocol.
Control Group: Participants in this group will receive only the standard IM injection protocol without any additional interventions.
Ethical Considerations:
Ethical approval was obtained from Gümüşhane University Scientific Research and Publication Ethics Committee (2024, E-95674917-108.99-291198) and written application permission from Van Provincial Health Directorate before data collection. Informed written and verbal consent will be obtained from all participants after explaining the study's purpose and content. Principles of informed consent, respect for participant autonomy, and confidentiality of personal information will be maintained during data collection. All participants will be informed of their right to withdraw from the study at any time.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: