Therapeutic Adherence and ComplianceNCT07673757
Therapeutic Touch for Intramuscular Injection Pain
A study testing Supportive Hand-Holding in people with Therapeutic Adherence and Compliance, run by Kilis 7 Aralik University at 1 site in Turkey (Türkiye).
Trial summary
The purpose of this study is to evaluate the effect of therapeutic touch on pain intensity associated with intramuscular injection and to examine the relationship between fear of pain and injection-related pain. Participants are assigned to either a therapeutic touch group or a control group. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Therapeutic Adherence and Compliance
- What is being tested?
- Supportive Hand-Holding
- Type of treatment
- Injection or infusion, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 3 May 2024to 30 Sep 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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Being between 18 and 60 years of age,
- Being literate,
- Being able to complete the Fear of Pain Questionnaire (FPQ) without missing items,
- Having no known allergy or contraindication to pheniramine hydrogen maleate,
- Not having lower respiratory tract disease/asthma and not being in pregnancy or lactation period,
- Having normal consciousness (adequate orientation and ability to follow commands),
- Not having a severe mood disorder.
Who cannot join
- Incomplete completion of the questionnaire/scale during the study,
- Having medical conditions that may affect pain perception, such as peripheral vascular disease, peripheral neuropathy, or diabetes.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Kilis 7 Aralık University, School of Health Services
Kilis, Kilis, 79000
About this study
Official title: Effect of Therapeutic Touch on Intramuscular Injection Pain: A Randomized Controlled Trial
The purpose of this study is to evaluate the effect of therapeutic touch on pain intensity associated with intramuscular injection and to examine the relationship between fear of pain and injection-related pain. Participants are assigned to either a therapeutic touch group or a control group. Pain intensity is assessed using a Visual Analog Scale (VAS), and fear of pain is assessed using the Fear of Pain Questionnaire.
- Conditions
- Therapeutic Adherence and Compliance
- Being tested
- Supportive Hand-Holding
- Keywords
- pain, fair of pain, Intramuscular Injection, nursing, Therapeutic Touch
- Medical subject headings
- Treatment Adherence and Compliance, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Supportive Hand-HoldingBehavioural
Also called Therapeutic Touch
This intervention involves supportive hand-holding by the patient's companion during the intramuscular injection. Immediately before the injection, the researcher briefly demonstrated to the companion how the hand should be held and provided simple guidance. During the injection, the companion held the patient's hand with both hands, offering a calm, silent, and emotionally supportive presence. The nurse was responsible only for administering the intramuscular injection and monitoring clinical safety; the nurse did not participate in the intervention itself. After the injection, the patient's pain level was assessed using the VAS scale based on self-report.
| Study group | Role | What they receive |
|---|---|---|
| Experimental: Therapeutic Touch | Experimental | In the intervention group, a supportive touch intervention was applied during the intramuscular injection to provide emotional support to the patient. Immediately before the injection, the researcher demonstrated the procedure to the patient's companion with a brief example and provided guidance on how the hand should be held. During the injection, the companion held the patient's hand with both hands, offering a calm, silent, and supportive presence. Throughout this process, the nurse was responsible only for administering the intramuscular injection and ensuring clinical safety; the nurse did not participate in the intervention. After the injection was completed, the patient's pain level was assessed using the VAS scale based on self-report. Receives: Behavioral: Supportive Hand-Holding |
| Control Group | No intervention | Participants in this group received no additional intervention; the intramuscular injection was administered in accordance with routine clinical practice. After the injection was completed, the patient's pain level was assessed using the same VAS scale based on self-report, as in the intervention group. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain Intensity (VAS Score)
Measured: Immediately after the intramuscular injection (within 2 minutes).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2026
- Study start3 May 2024
- Primary completion30 Sep 2024
- Study completion30 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Therapeutic Adherence and ComplianceStudies 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
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kilis 7 Aralik University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gülistan YURDAGÜL, Osmaniye Korkut Ata University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07673757
- Sponsor's protocol ID
- E.45023
- Status last verified
- Nov 2025
- First submitted
- 18 Nov 2025
- Last updated
- 29 Jun 2026
- 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 29 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Therapeutic Touch on Intramuscular Injection Pain: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07673757
- Acronym / sponsor ID
- E.45023
- Conditions
- Therapeutic Adherence and Compliance
- Keywords
- pain, fair of pain, Intramuscular Injection, nursing, Therapeutic Touch
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Kilis 7 Aralik UniversityUniversity, hospital or other
- Study start
- 3 May 2024 (actual)
- Primary completion
- 30 Sep 2024 (actual)
- Study completion
- 30 Sep 2024 (actual)
- First posted
- 29 Jun 2026 (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.
The purpose of this study is to evaluate the effect of therapeutic touch on pain intensity associated with intramuscular injection and to examine the relationship between fear of pain and injection-related pain. Participants are assigned to either a therapeutic touch group or a control group. Pain intensity is assessed using a Visual Analog Scale (VAS), and fear of pain is assessed using the Fear of Pain Questionnaire.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental: Therapeutic Touch | Experimental | Behavioral: Supportive Hand-HoldingIn the intervention group, a supportive touch intervention was applied during the intramuscular injection to provide emotional support to the patient. Immediately before the injection, the researcher demonstrated the procedure to the patient's companion with a brief example and provided guidance on how the hand should be held. During the injection, the companion held the patient's hand with both hands, offering a calm, silent, and supportive presence. Throughout this process, the nurse was responsible only for administering the intramuscular injection and ensuring clinical safety; the nurse did not participate in the intervention. After the injection was completed, the patient's pain level was assessed using the VAS scale based on self-report. |
| Control Group | No intervention | –Participants in this group received no additional intervention; the intramuscular injection was administered in accordance with routine clinical practice. After the injection was completed, the patient's pain level was assessed using the same VAS scale based on self-report, as in the intervention group. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Being between 18 and 60 years of age,
- Being literate,
- Being able to complete the Fear of Pain Questionnaire (FPQ) without missing items,
- Having no known allergy or contraindication to pheniramine hydrogen maleate,
- Not having lower respiratory tract disease/asthma and not being in pregnancy or lactation period,
Key exclusion criteria (2 listed)
- Incomplete completion of the questionnaire/scale during the study,
- Having medical conditions that may affect pain perception, such as peripheral vascular disease, peripheral neuropathy, or diabetes.
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 |
|---|---|---|
| Supportive Hand-HoldingAlso: Therapeutic TouchThis intervention involves supportive hand-holding by the patient's companion during the intramuscular injection. Immediately before the injection, the researcher briefly demonstrated to the companion how the hand should be held and provided simple guidance. During the injection, the companion held the patient's hand with both hands, offering a calm, silent, and emotionally supportive presence. The nurse was responsible only for administering the intramuscular injection and monitoring clinical safety; the nurse did not participate in the intervention itself. After the injection, the patient's pain level was assessed using the VAS scale based on self-report. | Behavioural | Experimental: Therapeutic Touch |
Primary outcome
Pain Intensity (VAS Score)
Time frame: Immediately after the intramuscular injection (within 2 minutes).
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 29 Jun 2026.
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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 Supportive Hand-Holding in people with Therapeutic Adherence and Compliance, run by Kilis 7 Aralik 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 7 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: finished, as of the sponsor's last update on 29 Jun 2026. 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?
Pain Intensity (VAS Score) (time frame: Immediately after the intramuscular injection (within 2 minutes).). 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 29 Jun 2026.