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Completed

NCT Number: NCT06932575

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.

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Key information

Conditions

Pain Management Agnosia Anxiety Disorders Anxiety Management Genital Diseases Infertility Mental Disorders Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Oocyte Retrieval Pain Pathological Conditions, Signs and Symptoms Perceptual Disorders Signs and Symptoms Urogenital Diseases

Age range

18 year–49 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Eskisehir Osmangazi University

Eskişehir, 26040, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Andullation Therapy Bed

Device

andullation therapy applied for 30 minutes after oocyte retrieval

Primary outcomes

  1. 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

Secondary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Eskisehir Osmangazi University

Other

Registry information

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Apr 17, 2025
Registry last updated
Apr 20, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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