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

NCT06932575 | Completed

• 1 other identifier: E-80558721-050.99-154981
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Pain Management; Anxiety Management; Oocyte Retrieval

Keywords

Infertility; Oocyte Retrieval; Andullation; Pain; Anxiety

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Anxiety Level after Oocyte Retrieval

  1, 1.5, 6, and 24 hours after oocyte retrieval

Study Arms (2)

The experimental group received andullation therapy

EXPERIMENTAL

The experimental group received andullation therapy for 30 minutes using an andullation therapy bed after oocyte retrieval

Device: Andullation Therapy Bed

The control group only applied scales

NO INTERVENTION

The control group did not receive andullation therapy after oocyte retrieval.

Interventions

Andullation Therapy Bed DEVICE

andullation therapy applied for 30 minutes after oocyte retrieval

The experimental group received andullation therapy

Eligibility Criteria

• Age: 18 Years - 49 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Eskisehir Osmangazi University: lead

Study Sites (1)

Eskisehir Osmangazi University

Eskişehir, Eskişehir, 26040, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Agnosia; Infertility; Pain; Anxiety Disorders

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Genital Diseases; Urogenital Diseases; Mental Disorders

Study Officials

• Assoc. Prof. VEHBİ YAVUZ TOKGÖZ

  Eskisehir Osmangazi University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: April 10, 2025
• First Posted: April 17, 2025
• Study Start: April 11, 2023
• Primary Completion: December 12, 2023
• Study Completion: December 12, 2023
• Last Updated: April 20, 2025

Record last verified: 2025-04

Locations

TU (1)