PainNCT05214703
The Effect of Cold Therapy on Pain and Anxiety During the Implanted Port Catheter Removal
A study testing cold therapy application in people with Pain and Anxiety, run by Yuksek Ihtisas University at 1 site in Turkey (Türkiye).
Trial summary
This study was conducted as a quasi-experimental study to examine the effect of cold therapy on pain and anxiety during venous port catheter removal. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- What is being tested?
- cold therapy application
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 112 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Feb 2018to 1 Sep 2018
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Clinical diagnosis of cancer disease
- 18 years and over
- no analgesic medication before three hours before the catheter removal procedure
- conscious and cooperative
- no communication problems
- no visual no vision problems
Show all 9Show fewer
- with stable vital signs
- without a diagnosis of anxiety disorder
- volunteer participation
Who cannot join
- Body mass index less than 18.5
- receiving Oxaliplatin infusions before venous port catheter removal
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Cold Therapy on Pain and Anxiety During the Implanted Port Catheter Removal Procedure
This study was conducted as a quasi-experimental study to examine the effect of cold therapy on pain and anxiety during venous port catheter removal.
Read the detailed description
Pain and anxiety experienced during diagnosis and treatment in cancer patients affect the physical, psychological, and interpersonal well-being of individuals and affect their lives in all aspects. Nurses play a very important role in pain control. Pain control is very important in terms of ensuring the comfort of patients and increasing their quality of life. In order to provide this control; nurses can use non-pharmacological treatment methods that they can apply independently in pain management. Patients experience procedural pain during insertion and removal of an implantable port catheter, which is one of the painful invasive procedures that are placed under the skin with a small incision, and insertion of a needle into the port catheter. When the literature is examined, it is seen that there are a limited number of studies in which non-pharmacological methods are used in the control of pain and anxiety related to the implantable venous port catheter procedure, and in these studies, distraction, music therapy, and inhaler aromatherapy. However, no study was found in which cold application was used to reduce the pain and anxiety caused by the removal of the port catheter in cancer patients. Therefore, the aim of the study is to evaluate the effectiveness of cold application on procedural pain and anxiety associated with port catheter removal, which is frequently used in the treatment of cancer patients. Cold therapy as an independent nursing intervention in reducing anxiety and pain management during port catheter removal in cancer/oncology patients; can be transferred to clinical practice by oncology nurses, improving the quality of nursing care, ensuring patient safety, and increasing patient satisfaction. In addition, the results of the research may contribute to the literature in terms of increasing evidence-based information on the use of the cold application in procedural pain and anxiety control in cancer patients.
- Being tested
- cold therapy application
- Keywords
- Cancer, Venous Port Catheter, Cold Therapy, Pain, Anxiety
- Medical subject headings
- Pain, Anxiety Disorders, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cold therapy applicationOther
cold therapy
| Study group | Role | What they receive |
|---|---|---|
| cold therapy | Experimental | Pain scores were measured with a visual analog scale (VAS) before the port catheter was removed from the patients in the experimental group. Before the port catheters were removed, cold application with an ice pack was applied to the patients whose first visual analog scale measurement was made by the researchers. The cold application was terminated an average of 15 minutes after the body temperature decreased by 1 °C. Receives: Other: cold therapy application |
| no intervention | No intervention | The patients in the control group did not receive any intervention before and after port catheter removal. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Vertical Visual Analog Scale(VAS)
Pain scores of the experimental and control groups were evaluated with VAS. The pain scores in both groups were shown to the patients by the researchers by showing the VAS, and they were asked to show at which point they experienced pain. The VAS scores of the patients in both groups were measured 10 minutes before the port catheter was removed (1st measurement), immediately after the catheter was removed (2nd measurement), and 10 minutes after the catheter was removed (3rd measurement).
Pain intensity was measured by using a vertical visual analog scale(VAS) from "0 to 10", with high numbers meaning greater pain intensity. Iıt is indicated that compared with other tools, the vas is more sensitive and reliable in the measurement of pain intensity. Pain intensity can be categorized as mild (score, 1-3), moderate (score, 4-6), and severe (score, 7-10) according to the scale.
Measured: 20 minutes
Secondary outcomes (1)
The StateTrait Anxiety Inventory(STAI-I)
The scores of the State-Trait Anxiety Inventory(STAI-I) Anxiety levels of the experimental and control groups were evaluated with STAI-I. The STAI-I scores of patients in both groups were measured 10 minutes before port catheter removal (1st measurement), and 10 minutes after catheter removal (2nd measurement).
The patient's level of anxiety was evaluated by the State-Trait Anxiety Inventory(STAI-I.). While the first 20 items in the scale determine the state anxiety level, the second 20 items evaluate the trait anxiety level. The scores obtained from both scales theoretically vary between 20-80. In terms of anxiety levels in STAI-I, "0-19 points" from the scale, no anxiety, "20-39" points mild, "40-59" points moderate, "60-79" points severe, "80" score is evaluated as the level of panic and severe anxiety.
Measured: 20 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2022
- Study start1 Feb 2018
- Primary completion1 Jun 2018
- Study completion1 Sep 2018
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 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
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Parallel Assignment a clinical trial with experimental and control groups with
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 112 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yuksek Ihtisas University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Arzu Bahar, Yuksek Ihtisas University
- Investigators
- Arzu bahar, PhD, Principal investigator, Yuksek Ihtisas University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05214703
- Sponsor's protocol ID
- YuksekIU-ABAHAR-002
- Status last verified
- Jan 2022
- First submitted
- 14 Jan 2022
- Last updated
- 31 Jan 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Bahar A, Aktas D, Sonmez M. Effects of Cold Therapy on Pain and Anxiety During Needle Removal From Implanted Ports. J Infus Nurs. 2023 Jan-Feb 01;46(1):36-42. doi: 10.1097/NAN.0000000000000495.
PubMed 36571826
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Cold Therapy on Pain and Anxiety During the Implanted Port Catheter Removal Procedure
- ClinicalTrials.gov ID
- NCT05214703
- Acronym / sponsor ID
- YuksekIU-ABAHAR-002
- Keywords
- Cancer, Venous Port Catheter, Cold Therapy, Pain, Anxiety
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 112 participants (actual)
- Lead sponsor
- Yuksek Ihtisas UniversityUniversity, hospital or other
- Study start
- 1 Feb 2018 (actual)
- Primary completion
- 1 Jun 2018 (actual)
- Study completion
- 1 Sep 2018 (actual)
- First posted
- 31 Jan 2022 (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 study was conducted as a quasi-experimental study to examine the effect of cold therapy on pain and anxiety during venous port catheter removal.
Detailed description
Pain and anxiety experienced during diagnosis and treatment in cancer patients affect the physical, psychological, and interpersonal well-being of individuals and affect their lives in all aspects. Nurses play a very important role in pain control. Pain control is very important in terms of ensuring the comfort of patients and increasing their quality of life. In order to provide this control; nurses can use non-pharmacological treatment methods that they can apply independently in pain management. Patients experience procedural pain during insertion and removal of an implantable port catheter, which is one of the painful invasive procedures that are placed under the skin with a small incision, and insertion of a needle into the port catheter. When the literature is examined, it is seen that there are a limited number of studies in which non-pharmacological methods are used in the control of pain and anxiety related to the implantable venous port catheter procedure, and in these studies, distraction, music therapy, and inhaler aromatherapy. However, no study was found in which cold application was used to reduce the pain and anxiety caused by the removal of the port catheter in cancer patients. Therefore, the aim of the study is to evaluate the effectiveness of cold application on procedural pain and anxiety associated with port catheter removal, which is frequently used in the treatment of cancer patients. Cold therapy as an independent nursing intervention in reducing anxiety and pain management during port catheter removal in cancer/oncology patients; can be transferred to clinical practice by oncology nurses, improving the quality of nursing care, ensuring patient safety, and increasing patient satisfaction. In addition, the results of the research may contribute to the literature in terms of increasing evidence-based information on the use of the cold application in procedural pain and anxiety control in cancer patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Parallel Assignment a clinical trial with experimental and control groups with
| Arm | Type | Receives |
|---|---|---|
| cold therapy | Experimental | Other: cold therapy applicationPain scores were measured with a visual analog scale (VAS) before the port catheter was removed from the patients in the experimental group. Before the port catheters were removed, cold application with an ice pack was applied to the patients whose first visual analog scale measurement was made by the researchers. The cold application was terminated an average of 15 minutes after the body temperature decreased by 1 °C. |
| no intervention | No intervention | –The patients in the control group did not receive any intervention before and after port catheter removal. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Clinical diagnosis of cancer disease
- 18 years and over
- no analgesic medication before three hours before the catheter removal procedure
- conscious and cooperative
- no communication problems
Key exclusion criteria (2 listed)
- Body mass index less than 18.5
- receiving Oxaliplatin infusions before venous port catheter removal
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 therapy applicationcold therapy | Other | cold therapy |
Primary outcome
Vertical Visual Analog Scale(VAS)
Time frame: 20 minutes
Pain scores of the experimental and control groups were evaluated with VAS. The pain scores in both groups were shown to the patients by the researchers by showing the VAS, and they were asked to show at which point they experienced pain. The VAS scores of the patients in both groups were measured 10 minutes before the port catheter was removed (1st measurement), immediately after the catheter was removed (2nd measurement), and 10 minutes after the catheter was removed (3rd measurement). Pain intensity was measured by using a vertical visual analog scale(VAS) from "0 to 10", with high numbers meaning greater pain intensity. Iıt is indicated that compared with other tools, the vas is more sensitive and reliable in the measurement of pain intensity. Pain intensity can be categorized as mild (score, 1-3), moderate (score, 4-6), and severe (score, 7-10) according to the scale.
1 secondary outcome
The StateTrait Anxiety Inventory(STAI-I)
Time frame: 20 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 31 Jan 2022.
- Derived from this study: PubMed 36571826Bahar A, Aktas D, Sonmez M. Effects of Cold Therapy on Pain and Anxiety During Needle Removal From Implanted Ports. J Infus Nurs. 2023 Jan-Feb 01;46(1):36-42. doi: 10.1097/NAN.0000000000000495.
- Individual participant dataSharing planned: No
Related trials for Pain
Not yet recruiting
Effect of Stress Ball Use During Femoral Arterial Sheath Removal After Coronary Angiography
Femoral Arterial Sheath Removal, Stress Ball
Recruiting
Empowered Relief® for Cancer Survivors With Chronic Pain
Chronic Pain Due to Cancer, Pain Catastrophizing
RecruitingPhase 4
ESP Blocks for Posterior Spinal Fusion
Postoperative Pain
RecruitingObservational study
Pain Phenotypes in Individuals With Multiple Sclerosis
Multiple Sclerosis, Chronic Pain
Not yet recruiting
Effects of Hip Hinge Exercises on Pain, Range of Motion and Functional Disability in Non-specific Low Back Pain.
Low Back Pain
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.
Arzu bahar, PhD principal investigator
Yuksek Ihtisas 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 cold therapy application in people with Pain and Anxiety, run by Yuksek Ihtisas 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 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: finished, as of the sponsor's last update on 31 Jan 2022. 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?
Vertical Visual Analog Scale(VAS) (time frame: 20 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 NCT05214703, 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 31 Jan 2022.