PainNCT05496647
Vırtual Reality, Music Therapy and Stress Ball-related Pain and Anxiety
A study testing Virtual Reality, Music Therapy and Stress Ball Application in people with Pain and Anxiety, run by Marmara University at 1 site in Turkey (Türkiye).
Trial summary
Outpatient surgical interventions; It is defined as surgical applications where the application time is short, the risk of complications is low, there is no need for intensive care after the intervention, and the patients can be discharged on the same day. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- What is being tested?
- Virtual Reality, Music Therapy and Stress Ball Application
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Jun 2022to 30 Jul 2022
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Over 18 years old,
- Can speak Turkish,
- Subjected to daily gynecological surgery for the first time,
- Does not have any psychiatric disease and mental perception problems,
- Having no vision, hearing, and perception problems,
- Having no physical problems squeezing a stress ball,
- There will be women who agree to participate in the research verbally and in writing.
Who cannot join
- Having used analgesic or anesthetic drugs within 24 hours before or during the procedure
- Using antidepressant, anxiolytic and sedative drugs
- Communication difficulties and mental disability
- Patients with severe vision and hearing problems, and physical disabilities (with open wounds on their hands, insufficient muscle strength to squeeze a stress ball) will not be included in the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect Of Vırtual Realıty, Musıc Therapy, And Stress Ball Applıcatıon On Paın And Anxıety Durıng Daıly Gynecologıcal Surgery
Outpatient surgical interventions; It is defined as surgical applications where the application time is short, the risk of complications is low, there is no need for intensive care after the intervention, and the patients can be discharged on the same day. It is applied in areas such as otolaryngology and maxillofacial surgery. Among all these areas, gynecological surgery is the area where the most outpatient surgery is performed. Some of the gynecological procedures that are generally applied in day surgery are as follows; Colposcopy, hysteroscopy, laparoscopy, dilatation-curettage, laparoscopic tubal ligation, treatment of the cervix with cautery or laser, removal of vulvar cysts, laser conization, cervical polypectomy and removal of Bartholin cysts.
In many state hospitals in our country, in daily gynecological surgical procedures; in some cases by premedication, in some cases under local anesthesia; however, patients are usually processed without anesthesia.
Read more
Virtual Reality, which is a type of computer system using human-machine interfaces, has been used in pain and anxiety management in different applications in many areas known as painful medical procedures in recent years.
Music therapy is defined as "the systematic use of music in a therapeutic relationship aimed at improving, maintaining and advancing emotional, physical and mental health". Music therapy has important physiological effects that reduce heart rate, blood pressure, body temperature, and respiratory rate, distract attention, increase the quality of life of patients, and reduce pain.
Stress ball emerges as a simple, reliable, inexpensive, and easily accessible method that helps patients reduce their anxiety. Squeezing the stress ball during the surgical procedure allows patients to have direct control over the object, increasing feelings of empowerment. In this way, it has a positive effect on anxiety and patient satisfaction without interfering with the surgical procedure. Based on all these reasons; The aim of this study is to determine the effects of virtual reality, music therapy, and stress ball applications on vital signs, pain, anxiety, and patient satisfaction during daily gynecological surgery.
Read the detailed description
Virtual Reality
Virtual Reality (VR) is a term formed from the words virtual and reality. According to the Turkish Language Association; Virtuality, which means unreal, or hypothetical, derives from the Latin word "virtual". The reality is; the real is defined as the whole of the things that exist and the truth. Virtual reality, which emerged as a concept in the 1950s, started to be used in application areas in the 1900s.
Virtual reality, which has been used only for space and military research as a computer-based, high-cost technology for years, has recently become widespread in the fields of medicine, education, entertainment, librarianship, museology, architecture, and industrial design with different applications developed for mobile devices.
Today, common and easily accessible android-based smart devices capable of running virtual reality are used. The image is obtained using a combination of framed simple optical lenses that hold the phone at a fixed distance perpendicular to the user's gaze direction. The working system of three-dimensional resuscitation devices is based on stereographic vision properties. After the relevant applications are installed on the smartphone, the device divides the screen into two, and thanks to the acquisition of different images for the right and left eyes, the illusion of the spatial existence of three-dimensional animated objects is obtained.
Virtual Reality is a simulation model that gives a sense of reality to its participants, is created based on computers, and allows mutual communication.
Virtual Reality Application in Pain and Anxiety Management
Virtual reality, which is a type of computer system using human-machine interfaces, has been used in the management of pain and anxiety in many different applications known as painful medical procedures in recent years. According to the researchers' hypotheses, virtual reality; acts as a non-pharmacological method using cognitive and attentional processes on the body's complex pain modulation system. Although its neurobiological mechanisms have not been fully explained, studies have interestingly reported that it brings positive results in pain management.
In virtual reality applications, patients feel that they are in the image, their attention is effectively distracted from the pain, and the perception of pain is reduced. In recent years, virtual reality as a distraction application; It is used in the management of pain and anxiety in procedures such as burn debridement, injection applications, wound care, toothache, endoscopy procedure, phantom, and chronic pain, and chemotherapy applications.
Music Therapy in Pain and Anxiety Management
Music therapy is a method that has been used frequently among complementary and alternative medicine applications for centuries. Music, which consists of regular, harmonious rhythms and sounds that we hear with our ears, is a behavior that expresses the aesthetics found in human nature. The therapeutic use of music has an active role in making people feel and communicate with their emotional dimension.
The first scientific theorist of the use of music therapy in treatment was Pythagoras. Today, a quintuple scale system is known as the 'Pythagorean Scale' or the 'Fiddler Scale'. For the ancient Greeks, music is considered the most basic element of spiritual education and purification of the soul from evil. Athennoaops aimed to alleviate the pain by playing an instrument in the area of pain by using the vibration effect. In Turkish-Islamic Civilization; According to great philosophers and scientists such as İbn-i Sina and Farabi, music not only improves the hearing power, but also the cognitive ability of people with the suggestions it creates. Music was also used in the treatment of mental illnesses with the melodies made by the Sufis who were dealing with Sufi music. XV-XVI. between the Kayseri Gevher Nesibe Medical Madrasa and Edirne Sultan II. The architecture of Ottoman-era hospitals such as the Bayezid Hospital was built in accordance with the isolation of patients, ventilation, and treatment with music.
Today, the effectiveness of music therapy as a complementary medicine application has been proven in many studies. American Music Therapy Association; reported that music significantly reduced pain and anxiety levels. There are studies stating that music is effective in pain during burn dressing and cancer-related pain, reduces opioid use after surgery, reduces the stress levels of patients during childbirth and different medical applications, and decreases blood pressure and pulse values.
music therapy; By focusing the patients on the rhythm of the music, distracts their attention from the pain, and activating the door control system, reduces the perception of pain. Music therapy increases the secretion of endorphins and relaxes the individual. music therapy; is used in the treatment of pain and anxiety as a non-pharmacological method that is easy to apply, economical, and has no side effects.
Stress Ball in Pain and Anxiety Management
A stress ball is a simple, reliable, inexpensive, and easily accessible method that helps reduce the anxiety of patients. It is stated that the use of stress balls generally relieves patients.
A stress ball, which is one of the distraction methods, is also an effective method in providing cognitive focus. It is seen in studies that stress ball application is used to reduce the anxiety and pain of patients. Squeezing a stress ball during the surgical procedure allows patients to have direct control over the object in their palm and increases patients' feelings of empowerment. Applying a stress ball in this way has a positive effect on anxiety and patient satisfaction without interfering with the surgical procedure. In another study; It has been found that holding a stress ball reduces both pain and anxiety in patients undergoing surgical procedures.
In the study of Yanes et al. to evaluate the effects of a stress ball or hand holding on pain, anxiety, and satisfaction in skin cancer surgery performed under local anesthesia, it was concluded that anxiety decreased in all groups. In the study, it was concluded that the stress ball helped reduce anxiety in patients who were anxious before the procedure. In the study conducted by Kasar et al. on hemodialysis patients, it was concluded that the use of a stress ball has a positive effect on stress.
In the study conducted to determine the effect of distraction methods used during the cystoscopy procedure on pain, anxiety, and satisfaction, it was concluded that the level of post-procedural anxiety was lower in the intervention groups (music, video, and stress ball) than the control group, and the satisfaction was higher.
In a randomized controlled study in which three different non-pharmacological methods (coughing technique, spirometer blowing, and stress ball squeezing) were evaluated in reducing pain during intravenous catheterization; It was concluded that the pain averages of the patients in the coughing technique, spirometer blowing and stress ball groups were lower than the control group.
In another study examining the effectiveness of distraction methods for pain and anxiety management during invasive venous surgery, it was concluded that pain and anxiety were significantly lower in the interaction with nurses and the stress ball group.
- Being tested
- Virtual Reality, Music Therapy, Stress Ball Application, Control
- Keywords
- Nursing, Virtual Reality, Music Therapy,, Stress Ball, Pain, Anxiety
- 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.
Virtual RealityOther
Before the surgical procedure; the Structured Patient Description Form, Fear of Pain Scale, Life Information Follow-up Form, State Anxiety Inventory, and Visual Comparison Scale forms will be filled by the researcher using a face-to-face interview technique with the woman.
During the process; the Preferred video will be watched with Virtual Reality Glasses for approximately 20 minutes during the process, After Daily Gynecological Surgery 1. Measurements; Immediately after the procedure, within the first 10 minutes; Life Information Follow-up Form, Visual Comparison Scale will be filled.
- Measurements After Daily Gynecological Surgery; At the 1st hour after the procedure, Vital Information Follow-up Form and Visual Comparison Scale will be filled.
- Measurements After Daily Gynecological Surgery; In the 2nd hour after the procedure; Life Information Follow-up Form, State Anxiety Inventory, Visual Comparison Scale and Satisfaction Evaluation Form will be filled.
Music TherapyOther
Before the surgical procedure; the Structured Patient Description Form, Fear of Pain Scale, Life Information Follow-up Form, State Anxiety Inventory, and Visual Comparison Scale forms will be filled by the researcher using a face-to-face interview technique with the woman.
During the process; During the procedure, the preferred music for Music Therapy will be played for approximately 20 minutes, After Daily Gynecological Surgery 1. Measurements; Immediately after the procedure, within the first 10 minutes; Life Information Follow-up Form and Visual Comparison Scale will be filled.
- Measurements After Daily Gynecological Surgery; In the 1st hour after the procedure, the Vital Information Follow-up Form and Visual Comparison Scale will be filled.
- Measurements After Daily Gynecological Surgery; In the 2nd hour after the procedure; Life Information Follow-up Form, State Anxiety Inventory, Visual Comparison Scale, and Satisfaction Evaluation Form will be filled.
Stress Ball ApplicationOther
Before the surgical procedure; the Structured Patient Description Form, Fear of Pain Scale, Life Information Follow-up Form, State Anxiety Inventory, and Visual Comparison Scale forms will be filled by the researcher using a face-to-face interview technique with the woman.
During the process; the Stress ball will be played for approximately 20 minutes during the process.
After Daily Gynecological Surgery 1. Measurements; Immediately after the procedure, within the first 10 minutes; Life Information Follow-up Form and Visual Comparison Scale will be filled.
- Measurements After Daily Gynecological Surgery; In the 1st hour after the procedure, the Vital Information Follow-up Form and Visual Comparison Scale will be filled.
- Measurements After Daily Gynecological Surgery; In the 2nd hour after the procedure; Life Information Follow-up Form, State Anxiety Inventory, Visual Comparison Scale, and Satisfaction Evaluation Form will be filled.
ControlOther
Before the surgical procedure; the Structured Patient Description Form, Fear of Pain Scale, Life Information Follow-up Form, State Anxiety Inventory, and Visual Comparison Scale forms will be filled by the researcher using a face-to-face interview technique with the woman.
During the process; Women in the control group will not undergo any intervention other than routine surgery.
After Daily Gynecological Surgery 1. Measurements; Immediately after the procedure, within the first 10 minutes; Life Information Follow-up Form and Visual Comparison Scale will be filled.
- Measurements After Daily Gynecological Surgery; In the 1st hour after the procedure, the Vital Information Follow-up Form and Visual Comparison Scale will be filled.
- Measurements After Daily Gynecological Surgery; In the 2nd hour after the procedure, the Life Information Follow-up Form, State Anxiety Inventory, Visual Comparison Scale, and Satisfaction Evaluation Form will be filled.
| Study group | Role | What they receive |
|---|---|---|
| Virtual Reality (VR) | Experimental | Virtual Reality Application (VR) VR group patients will be shown VR videos that include landscapes such as nature and the sea, giving people a feeling of comfort and peace, and making them feel like they are inside. During the surgical procedure, VR videos will be watched for an average of 20 minutes with X-brand VR glasses. In the research, similar studies will be examined and 360o VR video, which is a licensed product with atmospheric music background, containing relaxing nature images and nature sounds will be used. Receives: Other: Virtual Reality |
| Music Therapy | Experimental | Music Therapy Application During the surgical procedure, an mp3 player, and music therapy CDs of uşşak and Hüseyni will be used. (Oline will also create a list from music platforms (fizzy-Spotify, etc.)) Before starting the procedure, the patients will be asked about their music preferences and the music will be played to the patients (20 minutes) during the procedure in line with their preferences. Headphones provided by the researcher will be used for patients with headphones, and for patients without headphones.
The music authorities used (hüseyni and uşşak) will be provided and used by order, by obtaining the necessary permissions from the official site of TÜMATA. Receives: Other: Music Therapy |
| Stress Ball Application | Experimental | Stress Ball Application A sufficient number of stress balls will be provided by the investigator for each patient to use separately before starting the study. Before starting the day-to-day gynecological surgery, patients in the stress ball group will be given a round, colored, medium-hard, compressible Knaftmed ball made of high-quality silicone. To avoid implying that the procedure is inherently stressful, it will be referred to as a squeezing ball when instructing patients about stress ball application.
During the surgical procedure, it will be said that he can squeeze the stress ball as often as he wants for about 20-25 minutes and the stress ball will be given to each patient. Receives: Other: Stress Ball Application |
| Control | Experimental | During the process; Women in the control group will not undergo any intervention other than routine surgery. Receives: Other: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain Severity
Fear of Pain Scale-III; Participants mark the option that best describes the severity of their fear according to their pain experiences regarding the items listed on the scale. In the scoring, it means that 1- fear is never heard, and 5-fear is excessive. The lowest score that can be obtained in total is 30, and the highest score is 150.The lowest score that can be obtained for the sub-dimensions is 10, and the highest score is 50. The higher the individual's score on the scale, the higher the fear of pain.
Visual Analog Scale = VAS; In order to determine the severity of the pain experienced by the participants during and after the outpatient gynecological surgical procedure, score measurements in centimeters (cm) will be determined on the vertically prepared GCS. Visual Comparison Scale (0cm;No pain, 0.5cm- 3.0cm;Mild pain, 3.5cm-6.5cm;Moderate pain, 7.0cm-10.0cm;Severe pain).
Measured: 5 Months
Secondary outcomes (4)
Anxiety Intensity
The State Anxiety Inventory (STAI-S) will be used to measure the instantaneous anxiety levels before and after the surgical procedure, and the anxiety levels of the individuals will be determined. According to the results obtained, while the average anxiety scores are between 36 and 41, above this value indicates high anxiety level and below this value indicates low anxiety level.
Measured: 5 Months
Patient Information Form
Identifiable Information used by the sender is one of the first methods to be implemented. This section consists of education-training-gynecological 30th section such as age, educational status, educational status, social education.
Measured: 5 Months
Life Information Tracking Form
In the measurement of vital signs of individuals, devices that measure digital blood pressure and pulse, O2 saturation will be used by applying the necessary hygiene rules at patient transitions.
Measured: 5 Months
Patient Satisfaction Evaluation Form
Form, prepared by the researchers in line with the literature, consists of 11 questions questioning the satisfaction status of Virtual Reality, Music Therapy and Stress Ball applications, and a chart that starts with dissatisfaction (0) and shows the level of satisfaction (10).
Measured: 5 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2022
- Study start15 Jun 2022
- Primary completion30 Jul 2022
- Study completion30 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for PainStudies of the same condition, open and under way.
- More trials run by Marmara 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 160 participants (actual)
Sponsor and investigators
- Lead sponsor
- Marmara University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nurdan Demirci, Marmara University
- Investigators
- Tuğba öz, PhD RN, Principal investigator, Marmara University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05496647
- Sponsor's protocol ID
- MarmaraU-OZ-2022
- Status last verified
- Mar 2023
- First submitted
- 8 Aug 2022
- Last updated
- 14 Mar 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Oz T, Demirci N. The Effect of Virtual Reality, Music Therapy, and Stress Ball Application on Pain and Anxiety During Outpatient Gynecological Procedures: A Randomized Controlled Trial. J Perianesth Nurs. 2024 Dec;39(6):1034-1041. doi: 10.1016/j.jopan.2024.01.022. Epub 2024 May 25.
PubMed 38795085
Study at a glance
From the registry record, last updated by the sponsor on 14 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect Of Vırtual Realıty, Musıc Therapy, And Stress Ball Applıcatıon On Paın And Anxıety Durıng Daıly Gynecologıcal Surgery
- ClinicalTrials.gov ID
- NCT05496647
- Acronym / sponsor ID
- MarmaraU-OZ-2022
- Keywords
- Nursing, Virtual Reality, Music Therapy,, Stress Ball, Pain, Anxiety
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 160 participants (actual)
- Lead sponsor
- Marmara UniversityUniversity, hospital or other
- Study start
- 15 Jun 2022 (actual)
- Primary completion
- 30 Jul 2022 (actual)
- Study completion
- 30 Jul 2022 (actual)
- First posted
- 11 Aug 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.
Outpatient surgical interventions; It is defined as surgical applications where the application time is short, the risk of complications is low, there is no need for intensive care after the intervention, and the patients can be discharged on the same day. It is applied in areas such as otolaryngology and maxillofacial surgery. Among all these areas, gynecological surgery is the area where the most outpatient surgery is performed. Some of the gynecological procedures that are generally applied in day surgery are as follows; Colposcopy, hysteroscopy, laparoscopy, dilatation-curettage, laparoscopic tubal ligation, treatment of the cervix with cautery or laser, removal of vulvar cysts, laser conization, cervical polypectomy and removal of Bartholin cysts.
In many state hospitals in our country, in daily gynecological surgical procedures; in some cases by premedication, in some cases under local anesthesia; however, patients are usually processed without anesthesia.
Virtual Reality, which is a type of computer system using human-machine interfaces, has been used in pain and anxiety management in different applications in many areas known as painful medical procedures in recent years.
Music therapy is defined as "the systematic use of music in a therapeutic relationship aimed at improving, maintaining and advancing emotional, physical and mental health". Music therapy has important physiological effects that reduce heart rate, blood pressure, body temperature, and respiratory rate, distract attention, increase the quality of life of patients, and reduce pain.
Stress ball emerges as a simple, reliable, inexpensive, and easily accessible method that helps patients reduce their anxiety. Squeezing the stress ball during the surgical procedure allows patients to have direct control over the object, increasing feelings of empowerment. In this way, it has a positive effect on anxiety and patient satisfaction without interfering with the surgical procedure. Based on all these reasons; The aim of this study is to determine the effects of virtual reality, music therapy, and stress ball applications on vital signs, pain, anxiety, and patient satisfaction during daily gynecological surgery.
Detailed description
Virtual Reality
Virtual Reality (VR) is a term formed from the words virtual and reality. According to the Turkish Language Association; Virtuality, which means unreal, or hypothetical, derives from the Latin word "virtual". The reality is; the real is defined as the whole of the things that exist and the truth. Virtual reality, which emerged as a concept in the 1950s, started to be used in application areas in the 1900s.
Virtual reality, which has been used only for space and military research as a computer-based, high-cost technology for years, has recently become widespread in the fields of medicine, education, entertainment, librarianship, museology, architecture, and industrial design with different applications developed for mobile devices.
Today, common and easily accessible android-based smart devices capable of running virtual reality are used. The image is obtained using a combination of framed simple optical lenses that hold the phone at a fixed distance perpendicular to the user's gaze direction. The working system of three-dimensional resuscitation devices is based on stereographic vision properties. After the relevant applications are installed on the smartphone, the device divides the screen into two, and thanks to the acquisition of different images for the right and left eyes, the illusion of the spatial existence of three-dimensional animated objects is obtained.
Virtual Reality is a simulation model that gives a sense of reality to its participants, is created based on computers, and allows mutual communication.
Virtual Reality Application in Pain and Anxiety Management
Virtual reality, which is a type of computer system using human-machine interfaces, has been used in the management of pain and anxiety in many different applications known as painful medical procedures in recent years. According to the researchers' hypotheses, virtual reality; acts as a non-pharmacological method using cognitive and attentional processes on the body's complex pain modulation system. Although its neurobiological mechanisms have not been fully explained, studies have interestingly reported that it brings positive results in pain management.
In virtual reality applications, patients feel that they are in the image, their attention is effectively distracted from the pain, and the perception of pain is reduced. In recent years, virtual reality as a distraction application; It is used in the management of pain and anxiety in procedures such as burn debridement, injection applications, wound care, toothache, endoscopy procedure, phantom, and chronic pain, and chemotherapy applications.
Music Therapy in Pain and Anxiety Management
Music therapy is a method that has been used frequently among complementary and alternative medicine applications for centuries. Music, which consists of regular, harmonious rhythms and sounds that we hear with our ears, is a behavior that expresses the aesthetics found in human nature. The therapeutic use of music has an active role in making people feel and communicate with their emotional dimension.
The first scientific theorist of the use of music therapy in treatment was Pythagoras. Today, a quintuple scale system is known as the 'Pythagorean Scale' or the 'Fiddler Scale'. For the ancient Greeks, music is considered the most basic element of spiritual education and purification of the soul from evil. Athennoaops aimed to alleviate the pain by playing an instrument in the area of pain by using the vibration effect. In Turkish-Islamic Civilization; According to great philosophers and scientists such as İbn-i Sina and Farabi, music not only improves the hearing power, but also the cognitive ability of people with the suggestions it creates. Music was also used in the treatment of mental illnesses with the melodies made by the Sufis who were dealing with Sufi music. XV-XVI. between the Kayseri Gevher Nesibe Medical Madrasa and Edirne Sultan II. The architecture of Ottoman-era hospitals such as the Bayezid Hospital was built in accordance with the isolation of patients, ventilation, and treatment with music.
Today, the effectiveness of music therapy as a complementary medicine application has been proven in many studies. American Music Therapy Association; reported that music significantly reduced pain and anxiety levels. There are studies stating that music is effective in pain during burn dressing and cancer-related pain, reduces opioid use after surgery, reduces the stress levels of patients during childbirth and different medical applications, and decreases blood pressure and pulse values.
music therapy; By focusing the patients on the rhythm of the music, distracts their attention from the pain, and activating the door control system, reduces the perception of pain. Music therapy increases the secretion of endorphins and relaxes the individual. music therapy; is used in the treatment of pain and anxiety as a non-pharmacological method that is easy to apply, economical, and has no side effects.
Stress Ball in Pain and Anxiety Management
A stress ball is a simple, reliable, inexpensive, and easily accessible method that helps reduce the anxiety of patients. It is stated that the use of stress balls generally relieves patients.
A stress ball, which is one of the distraction methods, is also an effective method in providing cognitive focus. It is seen in studies that stress ball application is used to reduce the anxiety and pain of patients. Squeezing a stress ball during the surgical procedure allows patients to have direct control over the object in their palm and increases patients' feelings of empowerment. Applying a stress ball in this way has a positive effect on anxiety and patient satisfaction without interfering with the surgical procedure. In another study; It has been found that holding a stress ball reduces both pain and anxiety in patients undergoing surgical procedures.
In the study of Yanes et al. to evaluate the effects of a stress ball or hand holding on pain, anxiety, and satisfaction in skin cancer surgery performed under local anesthesia, it was concluded that anxiety decreased in all groups. In the study, it was concluded that the stress ball helped reduce anxiety in patients who were anxious before the procedure. In the study conducted by Kasar et al. on hemodialysis patients, it was concluded that the use of a stress ball has a positive effect on stress.
In the study conducted to determine the effect of distraction methods used during the cystoscopy procedure on pain, anxiety, and satisfaction, it was concluded that the level of post-procedural anxiety was lower in the intervention groups (music, video, and stress ball) than the control group, and the satisfaction was higher.
In a randomized controlled study in which three different non-pharmacological methods (coughing technique, spirometer blowing, and stress ball squeezing) were evaluated in reducing pain during intravenous catheterization; It was concluded that the pain averages of the patients in the coughing technique, spirometer blowing and stress ball groups were lower than the control group.
In another study examining the effectiveness of distraction methods for pain and anxiety management during invasive venous surgery, it was concluded that pain and anxiety were significantly lower in the interaction with nurses and the stress ball group.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Virtual Reality (VR) | Experimental | Other: Virtual RealityVirtual Reality Application (VR) VR group patients will be shown VR videos that include landscapes such as nature and the sea, giving people a feeling of comfort and peace, and making them feel like they are inside. During the surgical procedure, VR videos will be watched for an average of 20 minutes with X-brand VR glasses. In the research, similar studies will be examined and 360o VR video, which is a licensed product with atmospheric music background, containing relaxing nature images and nature sounds will be used. |
| Music Therapy | Experimental | Other: Music TherapyMusic Therapy Application During the surgical procedure, an mp3 player, and music therapy CDs of uşşak and Hüseyni will be used. (Oline will also create a list from music platforms (fizzy-Spotify, etc.)) Before starting the procedure, the patients will be asked about their music preferences and the music will be played to the patients (20 minutes) during the procedure in line with their preferences. Headphones provided by the researcher will be used for patients with headphones, and for patients without headphones. The music authorities used (hüseyni and uşşak) will be provided and used by order, by obtaining the necessary permissions from the official site of TÜMATA. |
| Stress Ball Application | Experimental | Other: Stress Ball ApplicationStress Ball Application A sufficient number of stress balls will be provided by the investigator for each patient to use separately before starting the study. Before starting the day-to-day gynecological surgery, patients in the stress ball group will be given a round, colored, medium-hard, compressible Knaftmed ball made of high-quality silicone. To avoid implying that the procedure is inherently stressful, it will be referred to as a squeezing ball when instructing patients about stress ball application. During the surgical procedure, it will be said that he can squeeze the stress ball as often as he wants for about 20-25 minutes and the stress ball will be given to each patient. |
| Control | Experimental | Other: ControlDuring the process; Women in the control group will not undergo any intervention other than routine surgery. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Over 18 years old,
- Can speak Turkish,
- Subjected to daily gynecological surgery for the first time,
- Does not have any psychiatric disease and mental perception problems,
- Having no vision, hearing, and perception problems,
Key exclusion criteria (4 listed)
- Having used analgesic or anesthetic drugs within 24 hours before or during the procedure
- Using antidepressant, anxiolytic and sedative drugs
- Communication difficulties and mental disability
- Patients with severe vision and hearing problems, and physical disabilities (with open wounds on their hands, insufficient muscle strength to squeeze a stress ball) will not be included in the study.
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 |
|---|---|---|
| Virtual RealityBefore the surgical procedure; the Structured Patient Description Form, Fear of Pain Scale, Life Information Follow-up Form, State Anxiety Inventory, and Visual Comparison Scale forms will be filled by the researcher using a face-to-face interview technique with the woman. During the process; the Preferred video will be watched with Virtual Reality Glasses for approximately 20 minutes during the process, After Daily Gynecological Surgery 1. Measurements; Immediately after the procedure, within the first 10 minutes; Life Information Follow-up Form, Visual Comparison Scale will be filled. 2. Measurements After Daily Gynecological Surgery; At the 1st hour after the procedure, Vital Information Follow-up Form and Visual Comparison Scale will be filled. 3. Measurements After Daily Gynecological Surgery; In the 2nd hour after the procedure; Life Information Follow-up Form, State Anxiety Inventory, Visual Comparison Scale and Satisfaction Evaluation Form will be filled. | Other | Virtual Reality (VR) |
| Music TherapyBefore the surgical procedure; the Structured Patient Description Form, Fear of Pain Scale, Life Information Follow-up Form, State Anxiety Inventory, and Visual Comparison Scale forms will be filled by the researcher using a face-to-face interview technique with the woman. During the process; During the procedure, the preferred music for Music Therapy will be played for approximately 20 minutes, After Daily Gynecological Surgery 1. Measurements; Immediately after the procedure, within the first 10 minutes; Life Information Follow-up Form and Visual Comparison Scale will be filled. 2. Measurements After Daily Gynecological Surgery; In the 1st hour after the procedure, the Vital Information Follow-up Form and Visual Comparison Scale will be filled. 3. Measurements After Daily Gynecological Surgery; In the 2nd hour after the procedure; Life Information Follow-up Form, State Anxiety Inventory, Visual Comparison Scale, and Satisfaction Evaluation Form will be filled. | Other | Music Therapy |
| Stress Ball ApplicationBefore the surgical procedure; the Structured Patient Description Form, Fear of Pain Scale, Life Information Follow-up Form, State Anxiety Inventory, and Visual Comparison Scale forms will be filled by the researcher using a face-to-face interview technique with the woman. During the process; the Stress ball will be played for approximately 20 minutes during the process. After Daily Gynecological Surgery 1. Measurements; Immediately after the procedure, within the first 10 minutes; Life Information Follow-up Form and Visual Comparison Scale will be filled. 2. Measurements After Daily Gynecological Surgery; In the 1st hour after the procedure, the Vital Information Follow-up Form and Visual Comparison Scale will be filled. 3. Measurements After Daily Gynecological Surgery; In the 2nd hour after the procedure; Life Information Follow-up Form, State Anxiety Inventory, Visual Comparison Scale, and Satisfaction Evaluation Form will be filled. | Other | Stress Ball Application |
| ControlBefore the surgical procedure; the Structured Patient Description Form, Fear of Pain Scale, Life Information Follow-up Form, State Anxiety Inventory, and Visual Comparison Scale forms will be filled by the researcher using a face-to-face interview technique with the woman. During the process; Women in the control group will not undergo any intervention other than routine surgery. After Daily Gynecological Surgery 1. Measurements; Immediately after the procedure, within the first 10 minutes; Life Information Follow-up Form and Visual Comparison Scale will be filled. 2. Measurements After Daily Gynecological Surgery; In the 1st hour after the procedure, the Vital Information Follow-up Form and Visual Comparison Scale will be filled. 3. Measurements After Daily Gynecological Surgery; In the 2nd hour after the procedure, the Life Information Follow-up Form, State Anxiety Inventory, Visual Comparison Scale, and Satisfaction Evaluation Form will be filled. | Other | Control |
Primary outcome
Pain Severity
Time frame: 5 Months
Fear of Pain Scale-III; Participants mark the option that best describes the severity of their fear according to their pain experiences regarding the items listed on the scale. In the scoring, it means that 1- fear is never heard, and 5-fear is excessive. The lowest score that can be obtained in total is 30, and the highest score is 150.The lowest score that can be obtained for the sub-dimensions is 10, and the highest score is 50. The higher the individual's score on the scale, the higher the fear of pain. Visual Analog Scale = VAS; In order to determine the severity of the pain experienced by the participants during and after the outpatient gynecological surgical procedure, score measurements in centimeters (cm) will be determined on the vertically prepared GCS. Visual Comparison Scale (0cm;No pain, 0.5cm- 3.0cm;Mild pain, 3.5cm-6.5cm;Moderate pain, 7.0cm-10.0cm;Severe pain).
4 secondary outcomes
Anxiety Intensity
Time frame: 5 Months
Patient Information Form
Time frame: 5 Months
Life Information Tracking Form
Time frame: 5 Months
Patient Satisfaction Evaluation Form
Time frame: 5 Months
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 14 Mar 2023.
- Derived from this study: PubMed 38795085Oz T, Demirci N. The Effect of Virtual Reality, Music Therapy, and Stress Ball Application on Pain and Anxiety During Outpatient Gynecological Procedures: A Randomized Controlled Trial. J Perianesth Nurs. 2024 Dec;39(6):1034-1041. doi: 10.1016/j.jopan.2024.01.022. Epub 2024 May 25.
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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.
Tuğba öz, PhD RN principal investigator
Marmara 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 Virtual Reality, Music Therapy and Stress Ball Application in people with Pain and Anxiety, run by Marmara 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 7 inclusion and 4 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 14 Mar 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?
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?
Pain Severity (time frame: 5 Months). 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 NCT05496647, which also lists 1 linked publication.
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 14 Mar 2023.