UreteroscopyNCT06758284
Effect of Laughter Yoga on Surgical Fear and Anxiety in Patients Applied Before Ureteroscopy
A study testing Laughter Yoga in people with Ureteroscopy and Kidney Stones, run by Kocaeli University at 1 site in Turkey (Türkiye).
Trial summary
Surgical fear is a situation where a person experiences excessive fear of surgical procedures. This fear can negatively affect the person's normal life and is usually more intense in the pre-operative period. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ureteroscopy, Kidney Stones
- What is being tested?
- Laughter Yoga
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 92 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jul 2024to 30 Dec 2024
- 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
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- It will be applied to patients who agree to participate in the study, are scheduled to undergo ureteroscopy in a urological surgery clinic, have no hearing or vision problems, are over the age of 18, understand and speak Turkish, are literate, and can communicate.
Who cannot join
- Patients with mental retardation and any psychiatric disorder, alcohol or drug addiction, hypertension or heart disease, hernia, glaucoma will be excluded.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Samsun Gazi State Hospital
Samsun, Samsun, 55000
About this study
Official title: Effect of Laughter Yoga on Surgical Fear and Anxiety in Patients Applied Before Ureteroscopy: a Randomized Controlled Trial
Surgical fear is a situation where a person experiences excessive fear of surgical procedures. This fear can negatively affect the person's normal life and is usually more intense in the pre-operative period. The causes of surgical fear include factors such as previous negative surgical experiences, lack of sufficient information, post-operative pain and complications. In addition, factors such as age, gender, and level of education can also affect fear. This fear can lead to physical and psychological problems along with stress; symptoms such as increased heart rate, dizziness, and muscle tension can be seen. Methods such as cognitive-behavioral therapy, meditation, and hypnosis can be used in the treatment of surgical fear. In addition, anxiety can also arise from thinking about the surgical procedure, post-operative complications, fear of anesthesia, or pain. High-risk surgeries and past negative experiences can increase anxiety. High anxiety before surgery can lead to psychological and physical problems. Nurses should offer anxiety-reducing techniques (breathing exercises, relaxation) by taking into account the needs of patients. In addition, having relatives with the patient can help relieve anxiety. Laughter yoga is considered an effective complementary therapy to reduce surgical fear and anxiety. Developed in India in 1995, this method involves simulating laughter with yoga breathing techniques. Laughter yoga relaxes muscles, increases pain threshold, and improves overall psychological well-being. This study aims to evaluate the effects of laughter yoga on patients undergoing ureteroscopy.
- Conditions
- Ureteroscopy, Kidney Stones
- Being tested
- Laughter Yoga
- Medical subject headings
- Kidney Calculi
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Laughter YogaOther
The first component of the intervention is laughter therapy, which is a combination of warm-up exercises, deep breathing exercises, childlike playfulness and laughter exercises. Participants will do laughter therapy via WhatsApp video call. Laughter yoga will be a single session and will last approximately 30 minutes.
| Study group | Role | What they receive |
|---|---|---|
| Laughter Yoga Group | Experimental | 1. 40 minutes before the procedure, the patients' surgical fear is evaluated.
2. 40 minutes before the procedure, the patients' state anxiety is evaluated.
3. A single session of laughter yoga is performed. (30 minutes)
4. After laughter yoga, the patients' surgical fear is re-evaluated.
5. After laughter yoga, the patients' state anxiety is re-evaluated. Receives: Other: Laughter Yoga |
| Control Group | No intervention | 1. 40 minutes before the procedure, the patients' surgical fear is evaluated. 2. 40 minutes before the procedure, the patients' situational anxiety is evaluated. 1. 5 minutes before the procedure, the patients' surgical fear is evaluated. 2. 5 minutes before the procedure, the patients' situational anxiety is evaluated. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Surgical Fear
The "Surgical Fear Questionnaire" will be used to measure patients' fear of surgery. The scale is an 11-point Likert-type scale consisting of 8 items, each item scored between 0 (not afraid at all) and 10 (very afraid). The scale has two sub-dimensions, each consisting of four items; items 1-4 measure fear of short-term outcomes of surgery, while items 5-8 measure fear of long-term outcomes of surgery. The sub-dimension scale score is obtained by summing the scores of each of the short-term and long-term sub-dimensions of the Surgical Fear Scale, and the total score of the scale is calculated by summing these scores. The sub-dimensions of the scale are scored between 0-40, and the total score is scored between 0-80. As the score increases, the patient's fear also increases.
Measured: 40 minutes before the ureteroscopy procedure, 5 minutes before the ureteroscopy procedure
Secondary outcomes (1)
Anxiety
Spielberg State-Trait Anxiety Inventory The scale consists of two separate dimensions: state anxiety (STAI-I) and trait anxiety (STAI-II), and these dimensions aim to measure individuals' anxiety in different contexts. The state anxiety section will be used in this study. The 20 items of the scale measure state anxiety. The scale items are in a 4-point Likert type. Responses range from "Never" (1) to "Very often" (4). The state anxiety scale contains 10 reverse (1, 2, 5, 8, 11, 15, 16, 19, 20) and 10 direct statements. The scale is scored between 20-80 and the anxiety level increases as the score increases.
Measured: 40 minutes before ureteroscopy, 5 minutes before ureteroscopy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jan 2025
- Study start1 Jul 2024
- Primary completion30 Dec 2024 (estimated)
- Study completion30 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for UreteroscopyStudies 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
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 92 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kocaeli University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hatice Merve Alptekin, Kocaeli University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06758284
- Sponsor's protocol ID
- 2024/11/16
- Status last verified
- Dec 2024
- First submitted
- 26 Dec 2024
- Last updated
- 3 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Laughter Yoga on Surgical Fear and Anxiety in Patients Applied Before Ureteroscopy: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06758284
- Acronym / sponsor ID
- 2024/11/16
- Conditions
- Ureteroscopy, Kidney Stones
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 92 participants (estimated)
- Lead sponsor
- Kocaeli UniversityUniversity, hospital or other
- Study start
- 1 Jul 2024 (actual)
- Primary completion
- 30 Dec 2024 (estimated)
- Study completion
- 30 Dec 2024 (estimated)
- First posted
- 3 Jan 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.
Surgical fear is a situation where a person experiences excessive fear of surgical procedures. This fear can negatively affect the person's normal life and is usually more intense in the pre-operative period. The causes of surgical fear include factors such as previous negative surgical experiences, lack of sufficient information, post-operative pain and complications. In addition, factors such as age, gender, and level of education can also affect fear. This fear can lead to physical and psychological problems along with stress; symptoms such as increased heart rate, dizziness, and muscle tension can be seen. Methods such as cognitive-behavioral therapy, meditation, and hypnosis can be used in the treatment of surgical fear. In addition, anxiety can also arise from thinking about the surgical procedure, post-operative complications, fear of anesthesia, or pain. High-risk surgeries and past negative experiences can increase anxiety. High anxiety before surgery can lead to psychological and physical problems. Nurses should offer anxiety-reducing techniques (breathing exercises, relaxation) by taking into account the needs of patients. In addition, having relatives with the patient can help relieve anxiety. Laughter yoga is considered an effective complementary therapy to reduce surgical fear and anxiety. Developed in India in 1995, this method involves simulating laughter with yoga breathing techniques. Laughter yoga relaxes muscles, increases pain threshold, and improves overall psychological well-being. This study aims to evaluate the effects of laughter yoga on patients undergoing ureteroscopy.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Laughter Yoga Group | Experimental | Other: Laughter Yoga1. 40 minutes before the procedure, the patients' surgical fear is evaluated. 2. 40 minutes before the procedure, the patients' state anxiety is evaluated. 3. A single session of laughter yoga is performed. (30 minutes) 4. After laughter yoga, the patients' surgical fear is re-evaluated. 5. After laughter yoga, the patients' state anxiety is re-evaluated. |
| Control Group | No intervention | –1. 40 minutes before the procedure, the patients' surgical fear is evaluated. 2. 40 minutes before the procedure, the patients' situational anxiety is evaluated. 1. 5 minutes before the procedure, the patients' surgical fear is evaluated. 2. 5 minutes before the procedure, the patients' situational anxiety is evaluated. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- It will be applied to patients who agree to participate in the study, are scheduled to undergo ureteroscopy in a urological surgery clinic, have no hearing or vision problems, are over the age of 18, understand and speak Turkish, are literate, and can communicate.
Key exclusion criteria (1 listed)
- Patients with mental retardation and any psychiatric disorder, alcohol or drug addiction, hypertension or heart disease, hernia, glaucoma will be excluded.
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 |
|---|---|---|
| Laughter YogaThe first component of the intervention is laughter therapy, which is a combination of warm-up exercises, deep breathing exercises, childlike playfulness and laughter exercises. Participants will do laughter therapy via WhatsApp video call. Laughter yoga will be a single session and will last approximately 30 minutes. | Other | Laughter Yoga Group |
Primary outcome
Surgical Fear
Time frame: 40 minutes before the ureteroscopy procedure, 5 minutes before the ureteroscopy procedure
The "Surgical Fear Questionnaire" will be used to measure patients' fear of surgery. The scale is an 11-point Likert-type scale consisting of 8 items, each item scored between 0 (not afraid at all) and 10 (very afraid). The scale has two sub-dimensions, each consisting of four items; items 1-4 measure fear of short-term outcomes of surgery, while items 5-8 measure fear of long-term outcomes of surgery. The sub-dimension scale score is obtained by summing the scores of each of the short-term and long-term sub-dimensions of the Surgical Fear Scale, and the total score of the scale is calculated by summing these scores. The sub-dimensions of the scale are scored between 0-40, and the total score is scored between 0-80. As the score increases, the patient's fear also increases.
1 secondary outcome
Anxiety
Time frame: 40 minutes before ureteroscopy, 5 minutes before ureteroscopy
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 3 Jan 2025.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Laughter Yoga in people with Ureteroscopy and Kidney Stones, run by Kocaeli 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 1 inclusion and 1 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: looking for participants now, as of the sponsor's last update on 3 Jan 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?
Contact Hatice Merve Alptekin research assistant (+902623034733, merve.alptekin@kocaeli.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Surgical Fear (time frame: 40 minutes before the ureteroscopy procedure, 5 minutes before the ureteroscopy procedure). 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 3 Jan 2025.