Clinical trial NCT06932575: The Effect of Andullation Therapy on Pain and Anxiety After Oocyte Retrieval
Official title: The Effect of Andullation Therapy on Pain and Anxiety After Oocyte Retrieval
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pain Management
Anxiety Management
Oocyte Retrieval
Keywords: Infertility
Oocyte Retrieval
Andullation
Pain
Anxiety
Lead sponsor: Eskisehir Osmangazi University
Sponsor class: OTHER
First posted: 2025-04-17
Enrollment: 60
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 49
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief 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. 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Pain Severity after Oocyte Retrieval
timeFrame: 1, 1.5, 6, and 24 hours after oocyte retrieval
Secondary outcomes:
measure: Anxiety Level after Oocyte Retrieval
timeFrame: 1, 1.5, 6, and 24 hours after oocyte retrieval
Other outcomes:
Locations:
city: Eskisehir
country: Turkey
facility: Eskisehir Osmangazi University
Study officials:
affiliation: Eskisehir Osmangazi University
name: Assoc. Prof. VEHBİ YAVUZ TOKGÖZ
role: PRINCIPAL_INVESTIGATOR
References: