Hand MassageNCT05937607
The Effect of the Hand Massage A Women Undergoing Brachytherapy
A study testing Hand massage in people with Hand Massage, run by TC Erciyes University at 1 site in Turkey (Türkiye).
Trial summary
Background Gynecologic cancers are among the ten most common cancers among women. During brachytherapy, women can have pain and situational anxiety due to the treatment. Methods This parallel-group randomized controlled study evaluated the effect of the hand massage practiced using baby oil, with lavender oil, on… Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Hand Massage
- What is being tested?
- Hand massage
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 14 Jun 2023to 15 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 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- verbal communication
- to be at the age of 18 and above
- to be diagnosed with gynecologic cancer and receive BT three days a week regularly
- to be aware that she has a gynecologic cancer disease and to be a volunteer to participate in the study
Who cannot join
- the patients who had metastasis, bleeding or coagulation disorder
- received complementary and integrated treatment
- had edema or lesion on hand, had a psychiatric disease
- had communication problems
- did not want to have a massage
- were under general anesthesia during the intervention
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of the Hand Massage Application on the Procedural Pain and State Anxiety of Women Undergoing Brachytherapy: A Parallel-Group Randomized Controlled Study
Background Gynecologic cancers are among the ten most common cancers among women. During brachytherapy, women can have pain and situational anxiety due to the treatment.
Methods This parallel-group randomized controlled study evaluated the effect of the hand massage practiced using baby oil, with lavender oil, on reducing operational pain and situational anxiety in women with brachytherapy. The study was completed with 36 patients. The treatment group included 18 patients, and the control group had 18. The data were collected through patient information form, visual analog scale, and state anxiety inventory. Before the brachytherapy, three sessions of hand massages, each lasting 10 minutes (5 minutes for each hand), were performed using baby oil with lavender. Data collection forms were repeated after each session. The control group received routine treatment. p<0.05 was accepted as significant.
Read the detailed description
Therefore, the impact of hand massage applied with lavender baby oil on women with gynecologic cancer having brachytherapy for three sessions on the pain and state anxiety experienced during the intervention was evaluated in this study.
- Conditions
- Hand Massage
- Being tested
- Hand massage
- Keywords
- Hand Massage, Pain, State Anxiety, Brachytherapy
- Medical subject headings
- Pain, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hand massageBehavioural
It is reported in the literature that the application should last 5-10 minutes on average to reduce acute pain, state anxiety, and provide physiological positive changes and relaxation in individuals during the procedure
| Study group | Role | What they receive |
|---|---|---|
| Hand massage | Experimental | hand massage was applied to the patients to receive intracavitary brachytherapy using lavender baby oil for three sessions of 10 minutes each, starting 5 minutes before the procedure. Receives: Behavioral: Hand massage |
| Control Group | No intervention | The control group did not receive any intervention during the study period |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Analog Scale
VAS is a form including numbers and is used in rating pain. Patients mark their pain on a 10 cm ruler with painlessness 0 written on the left end and the most severe pain possible 10 on the right end. It is stated that VAS is more sensitive and dependable in pain severity measurement when compared to other one-dimensional scales
Measured: The scale was filled in the baseline
Secondary outcomes (1)
State Anxiety Scale
The state anxiety scale is sensitive to the evaluation of suddenly changing emotive reactions; it is a Likert-type scale including 20 questions. The reversed items in the scale were 1st, 2nd, 5th, 8th, 10th, 11th, 15th, 16th, 19th, and 20th items. High scores indicate elevated levels of anxiety, and low scores low levels of anxiety. The total score from the scale ranges between 20 and 80.
Measured: The scale was filled in the baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2023
- Study start14 Jun 2023
- Primary completion15 Jul 2023 (estimated)
- Study completion15 Aug 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hand MassageStudies of the same condition, open and under way.
- More trials run by TC Erciyes 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
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- TC Erciyes University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dilek Efe Arslan, TC Erciyes University
- Investigators
- DİLEK EFE ARSLAN, PhD, Study director, ERCİYES UNİVERSİTY
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05937607
- Sponsor's protocol ID
- 815/795
- Status last verified
- Jul 2023
- First submitted
- 14 Jun 2023
- Last updated
- 10 Jul 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of the Hand Massage Application on the Procedural Pain and State Anxiety of Women Undergoing Brachytherapy: A Parallel-Group Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT05937607
- Acronym / sponsor ID
- 815/795
- Conditions
- Hand Massage
- Keywords
- Hand Massage, Pain, State Anxiety, Brachytherapy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- TC Erciyes UniversityUniversity, hospital or other
- Study start
- 14 Jun 2023 (actual)
- Primary completion
- 15 Jul 2023 (estimated)
- Study completion
- 15 Aug 2023 (estimated)
- First posted
- 10 Jul 2023 (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.
Background Gynecologic cancers are among the ten most common cancers among women. During brachytherapy, women can have pain and situational anxiety due to the treatment.
Methods This parallel-group randomized controlled study evaluated the effect of the hand massage practiced using baby oil, with lavender oil, on reducing operational pain and situational anxiety in women with brachytherapy. The study was completed with 36 patients. The treatment group included 18 patients, and the control group had 18. The data were collected through patient information form, visual analog scale, and state anxiety inventory. Before the brachytherapy, three sessions of hand massages, each lasting 10 minutes (5 minutes for each hand), were performed using baby oil with lavender. Data collection forms were repeated after each session. The control group received routine treatment. p<0.05 was accepted as significant.
Detailed description
Therefore, the impact of hand massage applied with lavender baby oil on women with gynecologic cancer having brachytherapy for three sessions on the pain and state anxiety experienced during the intervention was evaluated in this study.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hand massage | Experimental | Behavioral: Hand massagehand massage was applied to the patients to receive intracavitary brachytherapy using lavender baby oil for three sessions of 10 minutes each, starting 5 minutes before the procedure. |
| Control Group | No intervention | –The control group did not receive any intervention during the study period |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- verbal communication
- to be at the age of 18 and above
- to be diagnosed with gynecologic cancer and receive BT three days a week regularly
- to be aware that she has a gynecologic cancer disease and to be a volunteer to participate in the study
Key exclusion criteria (6 listed)
- the patients who had metastasis, bleeding or coagulation disorder
- received complementary and integrated treatment
- had edema or lesion on hand, had a psychiatric disease
- had communication problems
- did not want to have a massage
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 massageIt is reported in the literature that the application should last 5-10 minutes on average to reduce acute pain, state anxiety, and provide physiological positive changes and relaxation in individuals during the procedure | Behavioural | Hand massage |
Primary outcome
Visual Analog Scale
Time frame: The scale was filled in the baseline
VAS is a form including numbers and is used in rating pain. Patients mark their pain on a 10 cm ruler with painlessness 0 written on the left end and the most severe pain possible 10 on the right end. It is stated that VAS is more sensitive and dependable in pain severity measurement when compared to other one-dimensional scales
1 secondary outcome
State Anxiety Scale
Time frame: The scale was filled in the baseline
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jul 2023.
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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.
DİLEK EFE ARSLAN, PhD study director
ERCİYES UNİVERSİTY
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 Hand Massage, run by TC Erciyes 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 4 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 10 Jul 2023. 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?
Results are not available in the source record.
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?
Visual Analog Scale (time frame: The scale was filled in the baseline). 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 10 Jul 2023.