The Effect of Andullation Therapy on Pain and Anxiety After Oocyte Retrieval

April 16, 2025 updated by: Tuğba Kartal, Eskisehir Osmangazi University

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
60

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Eskisehir, Turkey, 26040
        • Eskisehir Osmangazi University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: The experimental group received andullation therapy
The experimental group received andullation therapy for 30 minutes using an andullation therapy bed after oocyte retrieval
Device: Andullation Therapy Bed
andullation therapy applied for 30 minutes after oocyte retrieval
No Intervention: The control group only applied scales
The control group did not receive andullation therapy after oocyte retrieval.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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, 1.5, 6, and 24 hours after oocyte retrieval

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Anxiety Level after Oocyte Retrieval
Time Frame: 1, 1.5, 6, and 24 hours 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.
1, 1.5, 6, and 24 hours after oocyte retrieval

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Eskisehir Osmangazi University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Eskisehir Osmangazi University Training and Research Hospital

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Assoc. Prof. VEHBİ YAVUZ TOKGÖZ, Eskisehir Osmangazi University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 11, 2023

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 12, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 12, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 10, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 10, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 17, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 20, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 16, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • E-80558721-050.99-154981
  • E-61749811-000-2226029 (Other Identifier: Turkish Ministry of Health, Turkish Medicines and Medical Devices Agency)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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