Pain ManagementNCT06932575
The Effect of Andullation Therapy on Pain and Anxiety After Oocyte Retrieval
A study testing Andullation Therapy Bed in people with Pain Management and Anxiety Management, run by Eskisehir Osmangazi University at 1 site in Turkey (Türkiye).
Trial summary
The goal of this clinical trial is to evaluate the effect of andullation therapy in the management of pain and anxiety that occur in the patient follow-up after oocyte retrieval. Read more about this study
- Who is it for?
- Ages 18 to 49 years, women only
- Conditions the study is for
- Pain Management, Anxiety Management, Oocyte Retrieval
- What is being tested?
- Andullation Therapy Bed
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 11 Apr 2023to 12 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 49 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Having an oocyte retrieval procedure regardless of the cause of infertility,
- Being at least literate,
- Being between the ages of 18-49,
- Accepting to participate in the study,
- Pain level above 0, as measured by the VAS scale, applied after the oocyte retrieval procedure.
Who cannot join
- Having chronic pain problems,
- Having communication problems,
- Having any nervous or musculoskeletal disorders that would prevent them from lying flat on the massage bed,
- Having any diagnosed psychiatric illness,
- Refusal to participate in the study.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Eskisehir Osmangazi University
Eskişehir, Eskişehir, 26040
About this study
The goal of this clinical trial is to evaluate the effect of andullation therapy in the management of pain and anxiety that occur in the patient follow-up after oocyte retrieval. The main questions it aims to answer are:
- Does andullation therapy after oocyte retrieval reduce pain measured immediately after the end of therapy?
- Does andullation therapy after oocyte retrieval reduce anxiety measured immediately after the end of therapy?
Read more
Researchers will compare experimental and control groups to see if andullation therapy reduce pain and anxiety after oocyte retrieval.
Participants will:
- Take State Anxiety Inventory before oocyte retrieval.
- Take andullation therapy or not after oocyte retrieval
- Take the State Anxiety Inventory and Visual Analog Scale at 1 hour, 1.5 hours, 6 hours, and 24 hours after oocyte retrieval.
Read the detailed description
During the oocyte retrieval procedure, midazolam, propofol, and remifentanil were administered intravenously by the anesthesia technician at doses determined by the anesthesiologist. During the two-hour period in which the women were closely monitored the procedure, 1 g of paracetamol vial recommended by the physician was administered intravenously by a reproductive health nurse to the women who stated that they had a lot of pain. Medical and technical details about the procedure and the patient, including the sedation protocol applied during oocyte retrieval, the number of oocytes collected, and whether a painkiller was administered was determined by the researcher based on information obtained from the physician and the patient's medical records.
In this study, the P05 relaxation program, one of the 10 different health programs of the andullation therapy bed, was used. Using the device control, the regional vibration intensity was set to 4, ensuring consistency across all regions. Infrared heat was activated in the neck and spine area with the H1 button and in the leg area with the H2 button. With this program, it was aimed to reduce anxiety by providing deep relaxation in the body and to provide the necessary energy for the body to repair itself.
to clearly show the duration of the effect of andullation therapy on pain and anxiety, intermittent scale applications were performed starting from before oocyte retrieval, when anxiety was thought to be the highest, until 24 hours after oocyte retrieval, when we expected the pain to gradually disappear.
- Conditions
- Pain Management, Anxiety Management, Oocyte Retrieval
- Being tested
- Andullation Therapy Bed
- Keywords
- Infertility, Oocyte Retrieval, Andullation, Pain, Anxiety
- Medical subject headings
- Agnosia, Infertility, Pain, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Andullation Therapy BedDevice
andullation therapy applied for 30 minutes after oocyte retrieval
| Study group | Role | What they receive |
|---|---|---|
| The experimental group received andullation therapy | Experimental | The experimental group received andullation therapy for 30 minutes using an andullation therapy bed after oocyte retrieval Receives: Device: Andullation Therapy Bed |
| The control group only applied scales | No intervention | The control group did not receive andullation therapy after oocyte retrieval. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain Severity after Oocyte Retrieval
Measure the relationship between pain severity in experimental and control groups after oocyte retrieval using Visual Analog Scale. In a 10-point VAS scoring: 0 indicates no pain, 1-3 indicates mild pain, 4-6 indicates moderate pain, and 7-10 indicates severe pain
Measured: 1, 1.5, 6, and 24 hours after oocyte retrieval
Secondary outcomes (1)
Anxiety Level after Oocyte Retrieval
Measure the relationship between anxiety level in experimental and control groups after oocyte retrieval using State Anxiety Inventory. The lowest score to be obtained from the scale is 20, and the highest score is 80. A cut-off score of 40 is commonly used to define possible levels of clinical anxiety. The higher the score on the scale, the higher the level of anxiety.
Measured: 1, 1.5, 6, and 24 hours after oocyte retrieval
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2025
- Study start11 Apr 2023
- Primary completion12 Dec 2023
- Study completion12 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pain ManagementStudies 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
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eskisehir Osmangazi University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tuğba Kartal, Eskisehir Osmangazi University
- Investigators
- Assoc. Prof. VEHBİ YAVUZ TOKGÖZ, Principal investigator, Eskisehir Osmangazi University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06932575
- Sponsor's protocol ID
- E-80558721-050.99-154981
- Status last verified
- Apr 2025
- First submitted
- 10 Apr 2025
- Last updated
- 20 Apr 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 20 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Andullation Therapy on Pain and Anxiety After Oocyte Retrieval
- ClinicalTrials.gov ID
- NCT06932575
- Acronym / sponsor ID
- E-80558721-050.99-154981
- Conditions
- Pain Management, Anxiety Management, Oocyte Retrieval
- Keywords
- Infertility, Oocyte Retrieval, Andullation, Pain, Anxiety
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Eskisehir Osmangazi UniversityUniversity, hospital or other
- Study start
- 11 Apr 2023 (actual)
- Primary completion
- 12 Dec 2023 (actual)
- Study completion
- 12 Dec 2023 (actual)
- First posted
- 17 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.
The goal of this clinical trial is to evaluate the effect of andullation therapy in the management of pain and anxiety that occur in the patient follow-up after oocyte retrieval. The main questions it aims to answer are:
- Does andullation therapy after oocyte retrieval reduce pain measured immediately after the end of therapy?
- Does andullation therapy after oocyte retrieval reduce anxiety measured immediately after the end of therapy?
Researchers will compare experimental and control groups to see if andullation therapy reduce pain and anxiety after oocyte retrieval.
Participants will:
- Take State Anxiety Inventory before oocyte retrieval.
- Take andullation therapy or not after oocyte retrieval
- Take the State Anxiety Inventory and Visual Analog Scale at 1 hour, 1.5 hours, 6 hours, and 24 hours after oocyte retrieval.
Detailed description
During the oocyte retrieval procedure, midazolam, propofol, and remifentanil were administered intravenously by the anesthesia technician at doses determined by the anesthesiologist. During the two-hour period in which the women were closely monitored the procedure, 1 g of paracetamol vial recommended by the physician was administered intravenously by a reproductive health nurse to the women who stated that they had a lot of pain. Medical and technical details about the procedure and the patient, including the sedation protocol applied during oocyte retrieval, the number of oocytes collected, and whether a painkiller was administered was determined by the researcher based on information obtained from the physician and the patient's medical records.
In this study, the P05 relaxation program, one of the 10 different health programs of the andullation therapy bed, was used. Using the device control, the regional vibration intensity was set to 4, ensuring consistency across all regions. Infrared heat was activated in the neck and spine area with the H1 button and in the leg area with the H2 button. With this program, it was aimed to reduce anxiety by providing deep relaxation in the body and to provide the necessary energy for the body to repair itself.
to clearly show the duration of the effect of andullation therapy on pain and anxiety, intermittent scale applications were performed starting from before oocyte retrieval, when anxiety was thought to be the highest, until 24 hours after oocyte retrieval, when we expected the pain to gradually disappear.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| The experimental group received andullation therapy | Experimental | Device: Andullation Therapy BedThe experimental group received andullation therapy for 30 minutes using an andullation therapy bed after oocyte retrieval |
| The control group only applied scales | No intervention | –The control group did not receive andullation therapy after oocyte retrieval. |
Who may qualify
- Ages
- 18 to 49 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Having an oocyte retrieval procedure regardless of the cause of infertility,
- Being at least literate,
- Being between the ages of 18-49,
- Accepting to participate in the study,
- Pain level above 0, as measured by the VAS scale, applied after the oocyte retrieval procedure.
Key exclusion criteria (5 listed)
- Having chronic pain problems,
- Having communication problems,
- Having any nervous or musculoskeletal disorders that would prevent them from lying flat on the massage bed,
- Having any diagnosed psychiatric illness,
- Refusal to participate 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 |
|---|---|---|
| Andullation Therapy Bedandullation therapy applied for 30 minutes after oocyte retrieval | Device | The experimental group received andullation therapy |
Primary outcome
Pain Severity after Oocyte Retrieval
Time frame: 1, 1.5, 6, and 24 hours after oocyte retrieval
Measure the relationship between pain severity in experimental and control groups after oocyte retrieval using Visual Analog Scale. In a 10-point VAS scoring: 0 indicates no pain, 1-3 indicates mild pain, 4-6 indicates moderate pain, and 7-10 indicates severe pain
1 secondary outcome
Anxiety Level after Oocyte Retrieval
Time frame: 1, 1.5, 6, and 24 hours after oocyte retrieval
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 20 Apr 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. This study is not recruiting at the moment.
Assoc. Prof. VEHBİ YAVUZ TOKGÖZ principal investigator
Eskisehir Osmangazi 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 Andullation Therapy Bed in people with Pain Management and Anxiety Management, run by Eskisehir Osmangazi 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 5 inclusion and 5 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 20 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?
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 after Oocyte Retrieval (time frame: 1, 1.5, 6, and 24 hours after oocyte retrieval). 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 20 Apr 2025.