CystoscopyNCT06949293
The Effect of Classical Hand Massage, Lavender Inhalation and Hand Massage With Lavender on Anxiety, Pain and Comfort
A study testing Hand massage with lavender oil, Classic hand massage and Lavender inhalation in people with Cystoscopy and Aromatherapy, run by Afide Tufan at 1 site in Turkey (Türkiye).
Trial summary
Cystoscopy is one of the most commonly performed urologic procedures to examine the anatomy and evaluate pathologies of the lower urinary tract. Although cystoscopy is a safe procedure with a low risk of morbidity, it can often cause pain, anxiety and restlessness in patients. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Cystoscopy, Aromatherapy, Hand Massage
- What is being tested?
- Hand massage with lavender oil, Classic hand massage and Lavender inhalation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 144 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Aug 2024to 30 Dec 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 years of age or older,
- Being a man
- Having cystoscopy for the first time,
- Local anesthesia will be performed,
- Rigid cystoscopy will be performed,
- No obstacles to communication,
Show all 9Show fewer
- Having a good sense of smell,
- No known history of allergy to the essential oil used,
- To agree to participate in the research
Who cannot join
- Having any contraindication for the procedure (urinary tract infection, lidocaine allergy, anatomical problems with the urethra, etc.),
- Having used any painkiller at least 24 hours before cystoscopy,
- Performing manipulations such as bladder biopsy, Double J catheter insertion or removal
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Classical Hand Massage, Lavender Inhalation and Hand Massage With Lavender on Anxiety, Pain and Comfort in Patients Undergoing Cystoscopy
Cystoscopy is one of the most commonly performed urologic procedures to examine the anatomy and evaluate pathologies of the lower urinary tract. Although cystoscopy is a safe procedure with a low risk of morbidity, it can often cause pain, anxiety and restlessness in patients. This study aims to determine the effects of classical hand massage, lavender inhalation and lavender hand massage applied to patients undergoing cystoscopy on the patient's anxiety, pain and comfort. The population of the study will consist of patients who underwent cystoscopy between July 2024 and April 2025. Data will be obtained with the Patient Identification Form, Vital Signs Follow-up Form, State Anxiety Scale, Numerical Pain Scale and Numerical Comfort Scale. The research will be conducted in three stages: before, during and after the cystoscopy procedure. In the pre-cystoscopy period, patients who meet the study inclusion criteria will be informed about the procedure and verbal and written permissions will be obtained. Randomization will be performed according to the order of application and the patients will be divided into four groups as the classical hand massage group, the lavender inhalation group, the lavender hand massage group and the control group. The Patient Identification Form will be filled in and the scales will be introduced. The vital signs of the patients in the intervention groups will be assessed half an hour before the procedure and the State Anxiety Scale will be filled in. In addition, a ten-minute application will be performed before the procedure and their vital signs and the State Anxiety Scale will be assessed five minutes after the procedure. During the cystoscopy period, after the patients in the intervention group are taken to the cystoscopy table and lidocaine gel is applied, their vital signs and pain levels will be assessed during the passage of the cystoscopy instrument from the urethra to the bladder. A ten-minute application will be performed during the procedure in the intervention groups and their vital signs and pain will be assessed immediately after the cystoscopy is completed. In the post-procedure period, half an hour after the cystoscopy procedure, the vital signs of the patients will be measured again, and the Numerical Pain Scale and Numerical Comfort Scale will be filled. The same data will be collected from the patients in the control group without any application.
Read the detailed description
Cystoscopy is one of the most commonly performed urological procedures to evaluate lower urinary tract symptoms such as hematuria and urinary incontinence as well as various pathologies of the urethra, prostate and bladder and to examine the anatomy of the lower urinary tract. Although cystoscopy is a safe procedure with a low risk of morbidity, it is invasive and can be associated with pain and anxiety. Cystoscopy is performed after a standard physical examination, disinfection of the external genital organs and instillation of some kind of lubricant into the urethra. In the majority of cases, general anesthesia is not required and it is performed under sedation or local anesthesia.However, some studies have shown that many patients report that they still feel pain during the procedure, although not at an uncomfortable level and for different reasons. Male patients are reported to experience more pain with rigid cystoscopy, first-time cystoscopies and cystoscopies to investigate lower urinary tract symptoms. Although cystoscopy is generally well tolerated, some patients describe the pain associated with the procedure as "excruciating".
Cystoscopy can often cause anxiety and discomfort. Especially in conscious patients, direct exposure to various stimuli during cystoscopy increases anxiety. Pain and anxiety associated with cystoscopy can activate the sympathetic nervous system, resulting in a variety of physiologic responses, including increased cardiac output, elevated blood glucose levels, peripheral vascular contraction, and elevated blood pressure.Often acute pain causes anxiety, which increases fear of pain and depression, sleep disturbances, and interferes with concentration and cognition. Anxiety about pain causes individuals to avoid the stimulus and overreact to the accompanying body sensations. Ensuring the comfort of patients before, during and after the cystoscopy procedure is necessary and important for the quality of care. Patients may experience discomfort and restlessness due to anxiety and stress. More than half of patients undergoing cystoscopy report moderate to severe discomfort, which is a significant problem for patients undergoing the procedure. It has also been found that men experience more discomfort than women.
There are various strategies to reduce anxiety and pain, including pharmacologic and nonpharmacologic methods. Although lidocaine lubricants, pain medications or flexible cystoscopy can be used to alleviate pain and anxiety during cystoscopy, the procedure still causes discomfort. Therefore, non-pharmacologic methods are needed to reduce pain and anxiety during the procedure and increase patient comfort and satisfaction. Non-pharmacological methods include aromatherapy, massage therapy, music therapy, hand holding, etc., which can be used alone or in combination with other methods. The advantages of these non-pharmacologic methods are that they are inexpensive, non-invasive, easy to apply and do not have chemical side effects.When the studies evaluating nursing care for the negative situations experienced by patients during cystoscopy were examined, it was found that listening to music during the procedure reduced patients' feelings of anxiety, pain, discomfort and dissatisfaction. There are also studies showing that the use of a virtual reality application during cystoscopy shortens the procedure time and reduces pain and discomfort. Hand holding during cystoscopy has also been shown to reduce patients' anxiety, pain and dissatisfaction. A study showed that watching relaxing videos during the procedure decreased pain, anxiety and hemodynamic parameters of female patients and increased their satisfaction levels. In another study conducted on women undergoing cystoscopy, it was determined that when patients' emotional, physical and informational needs were met, when they actively participated in their health care, when they had a say in their care, their fear of the unknown decreased and patient satisfaction increased.
In this study, the effect of classical hand massage, lavender inhalation and hand massage with lavender on reducing the anxiety of the patients before the cystoscopy procedure and the effect of the interventions during the procedure on reducing pain and increasing comfort will be evaluated. When the literature was examined, it was found that non-pharmacologic interventions applied during cystoscopy included distraction methods such as listening to music, virtual reality, watching relaxing videos, and squeezing a stress ball. There is no study showing whether classical hand massage, lavender inhalation and hand massage with lavender are effective in affecting the patient's anxiety, pain and comfort in patients undergoing cystoscopy. This study will be a first in this context. If the interventions applied to the intervention group are found to be effective, they can be recommended as methods that can be used routinely before and during the cystoscopy procedure. With this study, it is aimed to reduce the level of anxiety before cystoscopy procedure, to reduce pain during and after the procedure and to contribute to increase comfort.
- Conditions
- Cystoscopy, Aromatherapy, Hand Massage
- Being tested
- Hand massage with lavender oil, Classic hand massage, Lavender inhalation
- Keywords
- Aromatherapy, Pain, Anxiety, Hand Massage, Comfort, Cystoscopy
- 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 massage with lavender oilOther
Each hand of the patient will be massaged with lavender oil for 5 minutes before and during cystoscopy. Before the application, 5% lavender oil will be applied to a small part of the hand and this area will be monitored for signs of allergic reaction such as swelling and redness. If no allergic reaction is observed, the study will continue.
Classic hand massageOther
Each hand of the patient will be massaged with baby oil for 5 minutes before and during the cystoscopy procedure.
Lavender inhalationOther
Before and during the cystoscopy procedure, 2-3 drops of 5% lavender oil will be poured onto a 5x5 cm sterile gauze. It will be placed 10 cm away from the patient's nose and sniffed for 10 minutes.
| Study group | Role | What they receive |
|---|---|---|
| Classic hand massage group | Active comparator | Patients included in the study who are planned to undergo cystoscopy will be assigned to the classical hand massage group by matching them with the randomization table according to the order of arrival. There will be 36 patients in this group. Receives: Other: Classic hand massage |
| Lavender inhalation group | Active comparator | Patients included in the study who are planned to undergo cystoscopy will be assigned to the lavender inhalation group by matching them with the randomization table according to the order of arrival. There will be 36 patients in this group. Receives: Other: Lavender inhalation |
| Hand massage group with lavender oil | Active comparator | The patients included in the study who are planned to undergo cystoscopy will be assigned to the hand massage group with lavender oil by matching them with the randomization table according to the order of arrival. There will be 36 patients in this group. Receives: Other: Hand massage with lavender oil |
| Control group | No intervention | This group will not receive any intervention other than routine practice. There will be 36 patients in this group. |
What is being measured
The primary outcome is the main question the study is designed to answer.
participants' level of anxiety
State Anxiety Scale:The scale developed by Spielberg et al. in 1964 to measure the state anxiety levels of normal and abnormal individuals was adapted into Turkish by Öner and Le Compte (1983). It is a self-assessment type scale consisting of short statements. It was developed to measure a person's anxiety at a particular moment. The state anxiety scale, which consists of 20 items, is a scale that determines how an individual feels at a particular moment and condition. The emotions or behaviors expressed in the items of the SCS are answered by marking one of the options according to the degree of intensity (1) not at all, (2) a little, (3) a lot, (4) completely. There are 10 reversed statements in the inventory. These statements are items 1,2,5,8,10,11,15,16,19 and 20. The state anxiety score is calculated by adding 50 points to the difference between the total weighted scores of the direct and inverted statements. The scores obtained in the state anxiety scale theoretically vary betw
Measured: Perioperative
participants' level of pain
Numeric Pain Scale: This scale, which is intended to determine the severity of pain, aims to explain the patient's pain with numbers. The "0-10" numerical pain scale was used to assess the severity of the patients' pain. On numerical scales, pain starts with absence of pain (0) and reaches up to unbearable pain (10).
Measured: Perioperative
Number of Participants with high comfort rate
Numerical Comfort Scale: It is a 10 cm long, horizontally usable measurement tool for determining the comfort level, starting with "0- most uncomfortable" and ending with "10- most comfortable". A high score indicates a high comfort level
Measured: Perioperative
Body temperature of participants
The researcher will be measured with a digital non-contact thermometer.
Measured: Perioperative
Systolic and diastollic blood pressure of participants
The researcher will measure it using a digital blood pressure monitor.
Measured: Perioperative
Pulse rate of participants
The researcher will measure it using pulse oximetry
Measured: Perioperative
Oxygen saturation of participants
The researcher will measure it using pulse oximetry
Measured: Perioperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2025
- Study start15 Aug 2024
- Primary completion30 Jun 2025 (estimated)
- Study completion30 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for CystoscopyStudies 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
- 144 participants (actual)
Sponsor and investigators
- Lead sponsor
- Afide Tufan
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Afide Tufan, Saglik Bilimleri Universitesi
- Investigators
- Selda RIZALAR, Prof. Dr., Study director, The University of Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06949293
- Sponsor's protocol ID
- E-10840098-202.3.02-3033
- Status last verified
- Apr 2025
- First submitted
- 12 Apr 2025
- Last updated
- 29 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Kwon WA, Lee JW, Seo HK, Oh TH, Park SC, Jeong HJ, Seo IY. Hand-Holding during Cystoscopy Decreases Patient Anxiety, Pain, and Dissatisfaction: A Pilot Randomized Controlled Trial. Urol Int. 2018;100(2):222-227. doi: 10.1159/000485745. Epub 2017 Dec 22.
PubMed 29275402Krajewski W, Zdrojowy R, Wojciechowska J, Koscielska K, Dembowski J, Matuszewski M, Tupikowski K, Malkiewicz B, Kolodziej A. Patient comfort during flexible and rigid cystourethroscopy. Wideochir Inne Tech Maloinwazyjne. 2016;11(2):94-7. doi: 10.5114/wiitm.2016.60665. Epub 2016 Jun 17.
PubMed 27458489Laszkiewicz J, Krajewski W, Luczak M, Chorbinska J, Nowak L, Bardowska K, Zdrojowy R. Pain reduction methods during transurethral cystoscopy. Contemp Oncol (Pozn). 2021;25(2):80-87. doi: 10.5114/wo.2021.106652. Epub 2021 May 28.
PubMed 34667433Gezginci E, Bedir S, Ozcan C, Iyigun E. Does Watching a Relaxing Video During Cystoscopy Affect Pain and Anxiety Levels of Female Patients? A Randomized Controlled Trial. Pain Manag Nurs. 2021 Apr;22(2):214-219. doi: 10.1016/j.pmn.2020.08.005. Epub 2020 Sep 29.
PubMed 33008780
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Classical Hand Massage, Lavender Inhalation and Hand Massage With Lavender on Anxiety, Pain and Comfort in Patients Undergoing Cystoscopy
- ClinicalTrials.gov ID
- NCT06949293
- Acronym / sponsor ID
- E-10840098-202.3.02-3033
- Conditions
- Cystoscopy, Aromatherapy, Hand Massage
- Keywords
- Aromatherapy, Pain, Anxiety, Hand Massage, Comfort, Cystoscopy
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 144 participants (actual)
- Lead sponsor
- Afide TufanUniversity, hospital or other
- Study start
- 15 Aug 2024 (actual)
- Primary completion
- 30 Jun 2025 (estimated)
- Study completion
- 30 Dec 2025 (estimated)
- First posted
- 29 Apr 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.
Cystoscopy is one of the most commonly performed urologic procedures to examine the anatomy and evaluate pathologies of the lower urinary tract. Although cystoscopy is a safe procedure with a low risk of morbidity, it can often cause pain, anxiety and restlessness in patients. This study aims to determine the effects of classical hand massage, lavender inhalation and lavender hand massage applied to patients undergoing cystoscopy on the patient's anxiety, pain and comfort. The population of the study will consist of patients who underwent cystoscopy between July 2024 and April 2025. Data will be obtained with the Patient Identification Form, Vital Signs Follow-up Form, State Anxiety Scale, Numerical Pain Scale and Numerical Comfort Scale. The research will be conducted in three stages: before, during and after the cystoscopy procedure. In the pre-cystoscopy period, patients who meet the study inclusion criteria will be informed about the procedure and verbal and written permissions will be obtained. Randomization will be performed according to the order of application and the patients will be divided into four groups as the classical hand massage group, the lavender inhalation group, the lavender hand massage group and the control group. The Patient Identification Form will be filled in and the scales will be introduced. The vital signs of the patients in the intervention groups will be assessed half an hour before the procedure and the State Anxiety Scale will be filled in. In addition, a ten-minute application will be performed before the procedure and their vital signs and the State Anxiety Scale will be assessed five minutes after the procedure. During the cystoscopy period, after the patients in the intervention group are taken to the cystoscopy table and lidocaine gel is applied, their vital signs and pain levels will be assessed during the passage of the cystoscopy instrument from the urethra to the bladder. A ten-minute application will be performed during the procedure in the intervention groups and their vital signs and pain will be assessed immediately after the cystoscopy is completed. In the post-procedure period, half an hour after the cystoscopy procedure, the vital signs of the patients will be measured again, and the Numerical Pain Scale and Numerical Comfort Scale will be filled. The same data will be collected from the patients in the control group without any application.
Detailed description
Cystoscopy is one of the most commonly performed urological procedures to evaluate lower urinary tract symptoms such as hematuria and urinary incontinence as well as various pathologies of the urethra, prostate and bladder and to examine the anatomy of the lower urinary tract. Although cystoscopy is a safe procedure with a low risk of morbidity, it is invasive and can be associated with pain and anxiety. Cystoscopy is performed after a standard physical examination, disinfection of the external genital organs and instillation of some kind of lubricant into the urethra. In the majority of cases, general anesthesia is not required and it is performed under sedation or local anesthesia.However, some studies have shown that many patients report that they still feel pain during the procedure, although not at an uncomfortable level and for different reasons. Male patients are reported to experience more pain with rigid cystoscopy, first-time cystoscopies and cystoscopies to investigate lower urinary tract symptoms. Although cystoscopy is generally well tolerated, some patients describe the pain associated with the procedure as "excruciating".
Cystoscopy can often cause anxiety and discomfort. Especially in conscious patients, direct exposure to various stimuli during cystoscopy increases anxiety. Pain and anxiety associated with cystoscopy can activate the sympathetic nervous system, resulting in a variety of physiologic responses, including increased cardiac output, elevated blood glucose levels, peripheral vascular contraction, and elevated blood pressure.Often acute pain causes anxiety, which increases fear of pain and depression, sleep disturbances, and interferes with concentration and cognition. Anxiety about pain causes individuals to avoid the stimulus and overreact to the accompanying body sensations. Ensuring the comfort of patients before, during and after the cystoscopy procedure is necessary and important for the quality of care. Patients may experience discomfort and restlessness due to anxiety and stress. More than half of patients undergoing cystoscopy report moderate to severe discomfort, which is a significant problem for patients undergoing the procedure. It has also been found that men experience more discomfort than women.
There are various strategies to reduce anxiety and pain, including pharmacologic and nonpharmacologic methods. Although lidocaine lubricants, pain medications or flexible cystoscopy can be used to alleviate pain and anxiety during cystoscopy, the procedure still causes discomfort. Therefore, non-pharmacologic methods are needed to reduce pain and anxiety during the procedure and increase patient comfort and satisfaction. Non-pharmacological methods include aromatherapy, massage therapy, music therapy, hand holding, etc., which can be used alone or in combination with other methods. The advantages of these non-pharmacologic methods are that they are inexpensive, non-invasive, easy to apply and do not have chemical side effects.When the studies evaluating nursing care for the negative situations experienced by patients during cystoscopy were examined, it was found that listening to music during the procedure reduced patients' feelings of anxiety, pain, discomfort and dissatisfaction. There are also studies showing that the use of a virtual reality application during cystoscopy shortens the procedure time and reduces pain and discomfort. Hand holding during cystoscopy has also been shown to reduce patients' anxiety, pain and dissatisfaction. A study showed that watching relaxing videos during the procedure decreased pain, anxiety and hemodynamic parameters of female patients and increased their satisfaction levels. In another study conducted on women undergoing cystoscopy, it was determined that when patients' emotional, physical and informational needs were met, when they actively participated in their health care, when they had a say in their care, their fear of the unknown decreased and patient satisfaction increased.
In this study, the effect of classical hand massage, lavender inhalation and hand massage with lavender on reducing the anxiety of the patients before the cystoscopy procedure and the effect of the interventions during the procedure on reducing pain and increasing comfort will be evaluated. When the literature was examined, it was found that non-pharmacologic interventions applied during cystoscopy included distraction methods such as listening to music, virtual reality, watching relaxing videos, and squeezing a stress ball. There is no study showing whether classical hand massage, lavender inhalation and hand massage with lavender are effective in affecting the patient's anxiety, pain and comfort in patients undergoing cystoscopy. This study will be a first in this context. If the interventions applied to the intervention group are found to be effective, they can be recommended as methods that can be used routinely before and during the cystoscopy procedure. With this study, it is aimed to reduce the level of anxiety before cystoscopy procedure, to reduce pain during and after the procedure and to contribute to increase comfort.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Classic hand massage group | Active comparator | Other: Classic hand massagePatients included in the study who are planned to undergo cystoscopy will be assigned to the classical hand massage group by matching them with the randomization table according to the order of arrival. There will be 36 patients in this group. |
| Lavender inhalation group | Active comparator | Other: Lavender inhalationPatients included in the study who are planned to undergo cystoscopy will be assigned to the lavender inhalation group by matching them with the randomization table according to the order of arrival. There will be 36 patients in this group. |
| Hand massage group with lavender oil | Active comparator | Other: Hand massage with lavender oilThe patients included in the study who are planned to undergo cystoscopy will be assigned to the hand massage group with lavender oil by matching them with the randomization table according to the order of arrival. There will be 36 patients in this group. |
| Control group | No intervention | –This group will not receive any intervention other than routine practice. There will be 36 patients in this group. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 18 years of age or older,
- Being a man
- Having cystoscopy for the first time,
- Local anesthesia will be performed,
- Rigid cystoscopy will be performed,
Key exclusion criteria (3 listed)
- Having any contraindication for the procedure (urinary tract infection, lidocaine allergy, anatomical problems with the urethra, etc.),
- Having used any painkiller at least 24 hours before cystoscopy,
- Performing manipulations such as bladder biopsy, Double J catheter insertion or 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 |
|---|---|---|
| Hand massage with lavender oilEach hand of the patient will be massaged with lavender oil for 5 minutes before and during cystoscopy. Before the application, 5% lavender oil will be applied to a small part of the hand and this area will be monitored for signs of allergic reaction such as swelling and redness. If no allergic reaction is observed, the study will continue. | Other | Hand massage group with lavender oil |
| Classic hand massageEach hand of the patient will be massaged with baby oil for 5 minutes before and during the cystoscopy procedure. | Other | Classic hand massage group |
| Lavender inhalationBefore and during the cystoscopy procedure, 2-3 drops of 5% lavender oil will be poured onto a 5x5 cm sterile gauze. It will be placed 10 cm away from the patient's nose and sniffed for 10 minutes. | Other | Lavender inhalation group |
Primary outcome
participants' level of anxiety
Time frame: Perioperative
State Anxiety Scale:The scale developed by Spielberg et al. in 1964 to measure the state anxiety levels of normal and abnormal individuals was adapted into Turkish by Öner and Le Compte (1983). It is a self-assessment type scale consisting of short statements. It was developed to measure a person's anxiety at a particular moment. The state anxiety scale, which consists of 20 items, is a scale that determines how an individual feels at a particular moment and condition. The emotions or behaviors expressed in the items of the SCS are answered by marking one of the options according to the degree of intensity (1) not at all, (2) a little, (3) a lot, (4) completely. There are 10 reversed statements in the inventory. These statements are items 1,2,5,8,10,11,15,16,19 and 20. The state anxiety score is calculated by adding 50 points to the difference between the total weighted scores of the direct and inverted statements. The scores obtained in the state anxiety scale theoretically vary betw
participants' level of pain
Time frame: Perioperative
Numeric Pain Scale: This scale, which is intended to determine the severity of pain, aims to explain the patient's pain with numbers. The "0-10" numerical pain scale was used to assess the severity of the patients' pain. On numerical scales, pain starts with absence of pain (0) and reaches up to unbearable pain (10).
Number of Participants with high comfort rate
Time frame: Perioperative
Numerical Comfort Scale: It is a 10 cm long, horizontally usable measurement tool for determining the comfort level, starting with "0- most uncomfortable" and ending with "10- most comfortable". A high score indicates a high comfort level
Body temperature of participants
Time frame: Perioperative
The researcher will be measured with a digital non-contact thermometer.
Systolic and diastollic blood pressure of participants
Time frame: Perioperative
The researcher will measure it using a digital blood pressure monitor.
Pulse rate of participants
Time frame: Perioperative
The researcher will measure it using pulse oximetry
Oxygen saturation of participants
Time frame: Perioperative
The researcher will measure it using pulse oximetry
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2025.
- Background: PubMed 29275402Kwon WA, Lee JW, Seo HK, Oh TH, Park SC, Jeong HJ, Seo IY. Hand-Holding during Cystoscopy Decreases Patient Anxiety, Pain, and Dissatisfaction: A Pilot Randomized Controlled Trial. Urol Int. 2018;100(2):222-227. doi: 10.1159/000485745. Epub 2017 Dec 22.
- Background: PubMed 27458489Krajewski W, Zdrojowy R, Wojciechowska J, Koscielska K, Dembowski J, Matuszewski M, Tupikowski K, Malkiewicz B, Kolodziej A. Patient comfort during flexible and rigid cystourethroscopy. Wideochir Inne Tech Maloinwazyjne. 2016;11(2):94-7. doi: 10.5114/wiitm.2016.60665. Epub 2016 Jun 17.
- Background: PubMed 34667433Laszkiewicz J, Krajewski W, Luczak M, Chorbinska J, Nowak L, Bardowska K, Zdrojowy R. Pain reduction methods during transurethral cystoscopy. Contemp Oncol (Pozn). 2021;25(2):80-87. doi: 10.5114/wo.2021.106652. Epub 2021 May 28.
- Background: PubMed 33008780Gezginci E, Bedir S, Ozcan C, Iyigun E. Does Watching a Relaxing Video During Cystoscopy Affect Pain and Anxiety Levels of Female Patients? A Randomized Controlled Trial. Pain Manag Nurs. 2021 Apr;22(2):214-219. doi: 10.1016/j.pmn.2020.08.005. Epub 2020 Sep 29.
- 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.
Selda RIZALAR, Prof. Dr. study director
The University of Health Sciences
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 with lavender oil, Classic hand massage and Lavender inhalation in people with Cystoscopy and Aromatherapy, run by Afide Tufan 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 3 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: under way, not looking for participants, as of the sponsor's last update on 29 Apr 2025. 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?
This study is still under way. Results are not available in the source record yet.
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?
participants' level of anxiety (time frame: Perioperative). The study lists 7 primary outcomes in all. 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 NCT06949293, which also lists 4 linked publications.
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 Apr 2025.