AnxietyNCT05324527
The Effect of Preoperational Hand Massage Anxiety Level And Hemodynamic Variables
A study testing Hand Massage in people with Anxiety and Hemodynamic Instability, run by Mersin University at 1 site in Turkey (Türkiye).
Trial summary
The study was conducted randomly controlled experimental to determine the effect of hand massage applied to pre-operative children on anxiety level and physical symptoms of anxiety. Read more about this study
- Who is it for?
- Ages 9 to 12 years
- Conditions the study is for
- Anxiety, Hemodynamic Instability
- What is being tested?
- Hand Massage
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 84 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Apr 2017to 1 Sep 2017
- 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 9 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Agreeing to participate in the study and obtaining written permission from the family,
- Able to speak and understand Turkish,
- Not taking any analgesic and anesthetic drugs before the procedure,
- Over 9 years old and under 12 years old,
- whose parents are literate,
- Poor general condition and not needing emergency surgery (cases such as acute abdomen, intestinal perforations, traumas, etc.),
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- There is no open wound on the skin or an obstacle to massage (edema, abscess, skin infection with necrosis, etc.),
- Thrombophlebitis, occlusive artery disease, fever etc. who do not have a situation in which massage application is objectionable due to illness, He does not have conditions such as loss of sensation, mass, fracture and ingrown nails in his hand,
- Children who are conscious, fully oriented and cooperative and open to communication
Who cannot join
- Those who do not accept to participate in the research and do not get written permission from their families,
- Does not speak or understand Turkish
- Taking any analgesic and anesthetic drugs before the procedure,
- Less than 9 years old and over 12 years old,
- illiterate parents
- Poor general condition and emergency surgery (acute abdomen, intestinal perforations, traumas, etc.) cases) need,
Show all 10Show fewer
- Open wound on the skin or an obstacle to massage (edema, abscess, necrosis has occurred) skin infection etc.)
- Thrombophlebitis, occlusive artery disease, fever etc. massage practice due to illness having a situation where it is objectionable,
- Having conditions such as loss of sensation in the hand, mass, fracture and ingrown nails,
- Children who are unconscious, oriented and cooperative and not open to communication
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Preoperational Hand Massage Applied to Children on Anxiety Level And Hemodynamic Variables: A Randomized Controlled Trial
The study was conducted randomly controlled experimental to determine the effect of hand massage applied to pre-operative children on anxiety level and physical symptoms of anxiety.
Read the detailed description
On operation morning, "Child and Parent Introduction Form", "State-Trait Anxiety Inventory for Children" were read to and "Physiological Symptoms of Anxiety Inspection Form" measurement was done on children in both groups, and their 1st measurement values were recorded. Routine treatment and nursing care applications of the service were done preoperationally. After the researcher and the children in study group sat on a chair facing each other, hand massage procedure, 8 minutes to both hands and a total of 16 minutes hand massage was applied with liquid petrolatum. No massage was applied to children in control group. Right 16 minutes after the 1st filled forms in each group, "State-Trait Anxiety Inventory for Children", "Physiological Symptoms of Anxiety Inspection Form" were read, measurement was done and 2nd measurement values were recorded. Furthermore, "Satisfaction Evaluation Scale" was marked by those in study group after the massage, and measurement values were recorded.
- Conditions
- Anxiety, Hemodynamic Instability
- Being tested
- Hand Massage
- 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
Hand massage procedure, 8 minutes to both hands and a total of 16 minutes hand massage was applied with liquid petrolatum.
| Study group | Role | What they receive |
|---|---|---|
| Hand Massage Group | Experimental | After the researcher and the children in study group sat on a chair facing each other, hand massage procedure, 8 minutes to both hands and a total of 16 minutes hand massage was applied with liquid petrolatum. Receives: Other: Hand Massage |
| Control group | No intervention | The control group will be received routine treatment and care in the unit. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Anxiety evaluated using the State Anxiety Scale
Scores ranging from 20 to 80 points are obtained in the scale. In the total score obtained from the scale in scoring the scale, 0-19 points indicate the absence of anxiety, 20-39 points indicate mild anxiety, 40-59 points indicate moderate anxiety, and 60-79 points indicate severe anxiety level. Higher state anxiety scores indicate that anxiety level is also hig
Measured: Change from before implementation and after 16 minutes of practice (hand massage)
Secondary outcomes (4)
Blood pressure
systolic blood pressure (SBP), diastolic blood pressure (DBP), mmHg
Measured: Change from before implementation and after 16 minutes of practice (hand massage)
Heart rate
beats per minute
Measured: Change from before implementation and after 16 minutes of practice (hand massage)
respiratory rate
ekspiration and inspiration per minute
Measured: Change from before implementation and after 16 minutes of practice (hand massage)
peripheral oxygen saturation
%, percentage of oxygenated hemoglobin in peripheral arterial blood
Measured: Change from before implementation and after 16 minutes of practice (hand massage)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2022
- Study start1 Apr 2017
- Primary completion1 Sep 2017
- Study completion1 Sep 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnxietyStudies of the same condition, open and under way.
- More trials run by Mersin UniversityThe sponsor's other registered studies.
- 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
- Model description
- Prospective, parallel, two-arm, randomized controlled clinical trial
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 84 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mersin University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Didem Lafci, Mersin University
- Investigators
- Fahri AŞKAN, Master, Principal investigator, 100. Year University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05324527
- Sponsor's protocol ID
- MersinUniv
- Status last verified
- Apr 2022
- First submitted
- 25 Mar 2022
- Last updated
- 12 Apr 2022
- 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 12 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Preoperational Hand Massage Applied to Children on Anxiety Level And Hemodynamic Variables: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05324527
- Acronym / sponsor ID
- MersinUniv
- Conditions
- Anxiety, Hemodynamic Instability
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 84 participants (actual)
- Lead sponsor
- Mersin UniversityUniversity, hospital or other
- Study start
- 1 Apr 2017 (actual)
- Primary completion
- 1 Sep 2017 (actual)
- Study completion
- 1 Sep 2017 (actual)
- First posted
- 12 Apr 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.
The study was conducted randomly controlled experimental to determine the effect of hand massage applied to pre-operative children on anxiety level and physical symptoms of anxiety.
Detailed description
On operation morning, "Child and Parent Introduction Form", "State-Trait Anxiety Inventory for Children" were read to and "Physiological Symptoms of Anxiety Inspection Form" measurement was done on children in both groups, and their 1st measurement values were recorded. Routine treatment and nursing care applications of the service were done preoperationally. After the researcher and the children in study group sat on a chair facing each other, hand massage procedure, 8 minutes to both hands and a total of 16 minutes hand massage was applied with liquid petrolatum. No massage was applied to children in control group. Right 16 minutes after the 1st filled forms in each group, "State-Trait Anxiety Inventory for Children", "Physiological Symptoms of Anxiety Inspection Form" were read, measurement was done and 2nd measurement values were recorded. Furthermore, "Satisfaction Evaluation Scale" was marked by those in study group after the massage, and measurement values were recorded.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Prospective, parallel, two-arm, randomized controlled clinical trial
| Arm | Type | Receives |
|---|---|---|
| Hand Massage Group | Experimental | Other: Hand MassageAfter the researcher and the children in study group sat on a chair facing each other, hand massage procedure, 8 minutes to both hands and a total of 16 minutes hand massage was applied with liquid petrolatum. |
| Control group | No intervention | –The control group will be received routine treatment and care in the unit. |
Who may qualify
- Ages
- 9 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (9 listed)
- Agreeing to participate in the study and obtaining written permission from the family,
- Able to speak and understand Turkish,
- Not taking any analgesic and anesthetic drugs before the procedure,
- Over 9 years old and under 12 years old,
- whose parents are literate,
Key exclusion criteria (10 listed)
- Those who do not accept to participate in the research and do not get written permission from their families,
- Does not speak or understand Turkish
- Taking any analgesic and anesthetic drugs before the procedure,
- Less than 9 years old and over 12 years old,
- illiterate parents
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 MassageHand massage procedure, 8 minutes to both hands and a total of 16 minutes hand massage was applied with liquid petrolatum. | Other | Hand Massage Group |
Primary outcome
Anxiety evaluated using the State Anxiety Scale
Time frame: Change from before implementation and after 16 minutes of practice (hand massage)
Scores ranging from 20 to 80 points are obtained in the scale. In the total score obtained from the scale in scoring the scale, 0-19 points indicate the absence of anxiety, 20-39 points indicate mild anxiety, 40-59 points indicate moderate anxiety, and 60-79 points indicate severe anxiety level. Higher state anxiety scores indicate that anxiety level is also hig
4 secondary outcomes
Blood pressure
Time frame: Change from before implementation and after 16 minutes of practice (hand massage)
Heart rate
Time frame: Change from before implementation and after 16 minutes of practice (hand massage)
respiratory rate
Time frame: Change from before implementation and after 16 minutes of practice (hand massage)
peripheral oxygen saturation
Time frame: Change from before implementation and after 16 minutes of practice (hand massage)
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 12 Apr 2022.
- 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.
Fahri AŞKAN, Master principal investigator
100. Year 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 Hand Massage in people with Anxiety and Hemodynamic Instability, run by Mersin 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 10 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 12 Apr 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?
Anxiety evaluated using the State Anxiety Scale (time frame: Change from before implementation and after 16 minutes of practice (hand massage)). 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 12 Apr 2022; AzTrials last refreshed its copy on 7 Nov 2026.