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

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: Completed
• Conditions: Pain Management; Oocyte Retrieval; Anxiety Management
• Intervention / Treatment: Device: Andullation Therapy Bed

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: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

Outcome Measure	Measure Description	Time Frame
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	1, 1.5, 6, and 24 hours after oocyte retrieval

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	1, 1.5, 6, and 24 hours after oocyte retrieval

Collaborators and Investigators

• Sponsor: Eskisehir Osmangazi University
• Collaborators: Eskisehir Osmangazi University Training and Research Hospital
• Investigators: Principal Investigator: Assoc. Prof. VEHBİ YAVUZ TOKGÖZ, Eskisehir Osmangazi University

Study record dates

Study Major Dates

• Study Start (Actual): April 11, 2023
• Primary Completion (Actual): December 12, 2023
• Study Completion (Actual): December 12, 2023

Study Registration Dates

• First Submitted: April 10, 2025
• First Submitted That Met QC Criteria: April 10, 2025
• First Posted (Actual): April 17, 2025

Study Record Updates

• Last Update Posted (Actual): April 20, 2025
• Last Update Submitted That Met QC Criteria: April 16, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Keywords: Pain; Anxiety; Infertility; Oocyte Retrieval; Andullation
• Additional Relevant MeSH Terms: Mental Disorders; Anxiety Disorders
• Other Study ID 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