Chemotherapy EffectNCT07114328
The Effect of Hand Massage Application
A study testing hand massage in people with Chemotherapy Effect, run by Mersin University at 2 sites in Turkey (Türkiye).
Trial summary
This study was conducted to investigate the effects of hand massage applied before needle insertion into the port catheter on anxiety and vital signs in cancer patients with port catheters. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Chemotherapy Effect
- What is being tested?
- hand massage
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 2 sitesTurkey (Türkiye)
- Study dates
- 15 Mar 2023to 30 Aug 2023
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Individuals who agreed to participate in the study
- Received treatment in the Outpatient Chemotherapy Unit
Who cannot join
- Who had a wound, deformity, or lesion on the hand
- Who had inflammation, or a lesion, or similar, at the implantable venous port catheter site
Trial locations and contacts
2 sites in 1 country.
Turkey (Türkiye)2 sites
Mersin University
Mersin, Mersin, 33110
Mersin University
Mersin, Yenişehir, 33110
About this study
Official title: The Effect of Hand Massage Application Before Venous Port Catheter Needle Insertion on Anxiety and Vital Signs in Patients Receiving Chemotherapy: a Randomized Controlled Trial
This study was conducted to investigate the effects of hand massage applied before needle insertion into the port catheter on anxiety and vital signs in cancer patients with port catheters.
Read the detailed description
This study was conducted as a randomized controlled trial. A total of 80 patients were randomly assigned to the hand massage (n=40) and control (n=40) groups. Data were collected using the "Individual Introduction Form," "Vital Signs Monitoring Form," and "State Anxiety Inventory." The hand massage group received hand massage before port catheter needle insertion. The control group received standard care without any additional interventions.
- Conditions
- Chemotherapy Effect
- Being tested
- hand massage
- Keywords
- Anxiety, Hand massage, Port Catheter, Vital Signs
- Medical subject headings
- Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
hand massageOther
The hand massage was applied to both hands for 5-6 minutes, for a total of 10-12 minutes
| Study group | Role | What they receive |
|---|---|---|
| hand massage | Experimental | The hand massage was applied to both hands for 5-6 minutes, for a total of 10-12 minutes Receives: Other: hand massage |
| control | No intervention | no intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Anxiety
State Trait Anxiety Inventory - STAI: The total score from the scale ranges from 20 to 80, with higher scores indicating higher anxiety levels and lower scores indicating lower anxiety levels.
Measured: • Before the hand massage on day 1 • The hand massage on day 1, immediately after the port catheter needle is inserted • After the end of chemotherapy on day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2025
- Study start15 Mar 2023
- Primary completion30 Jul 2023
- Study completion30 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chemotherapy EffectStudies 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mersin University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Birgul Vural Dogru, Mersin University
- Investigators
- Birgül VURAL DOĞRU, Principal investigator, Mersin University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07114328
- Sponsor's protocol ID
- 2022-831
- Other IDs
- 2022-831, 2022-831
- Status last verified
- Aug 2025
- First submitted
- 24 Jul 2025
- Last updated
- 11 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Hand Massage Application Before Venous Port Catheter Needle Insertion on Anxiety and Vital Signs in Patients Receiving Chemotherapy: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07114328
- Acronym / sponsor ID
- 2022-831
- Conditions
- Chemotherapy Effect
- Keywords
- Anxiety, Hand massage, Port Catheter, Vital Signs
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Mersin UniversityUniversity, hospital or other
- Study start
- 15 Mar 2023 (actual)
- Primary completion
- 30 Jul 2023 (actual)
- Study completion
- 30 Aug 2023 (actual)
- First posted
- 11 Aug 2025 (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 to investigate the effects of hand massage applied before needle insertion into the port catheter on anxiety and vital signs in cancer patients with port catheters.
Detailed description
This study was conducted as a randomized controlled trial. A total of 80 patients were randomly assigned to the hand massage (n=40) and control (n=40) groups. Data were collected using the "Individual Introduction Form," "Vital Signs Monitoring Form," and "State Anxiety Inventory." The hand massage group received hand massage before port catheter needle insertion. The control group received standard care without any additional interventions.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| hand massage | Experimental | Other: hand massageThe hand massage was applied to both hands for 5-6 minutes, for a total of 10-12 minutes |
| control | No intervention | –no intervention |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Individuals who agreed to participate in the study
- Received treatment in the Outpatient Chemotherapy Unit
Key exclusion criteria (2 listed)
- Who had a wound, deformity, or lesion on the hand
- Who had inflammation, or a lesion, or similar, at the implantable venous port catheter site
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 |
|---|---|---|
| hand massageThe hand massage was applied to both hands for 5-6 minutes, for a total of 10-12 minutes | Other | hand massage |
Primary outcome
Anxiety
Time frame: • Before the hand massage on day 1 • The hand massage on day 1, immediately after the port catheter needle is inserted • After the end of chemotherapy on day 1
State Trait Anxiety Inventory - STAI: The total score from the scale ranges from 20 to 80, with higher scores indicating higher anxiety levels and lower scores indicating lower anxiety levels.
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 11 Aug 2025.
- 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.
Birgül VURAL DOĞRU principal investigator
Mersin University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing hand massage in people with Chemotherapy Effect, run by Mersin University at 2 sites 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 2 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 11 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Anxiety (time frame: • Before the hand massage on day 1 • The hand massage on day 1, immediately after the port catheter needle is inserted • After the end of chemotherapy on day 1). 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 11 Aug 2025.