The Effect of Stress Ball Used During Intra Uterine Insemination on Pain, Anxiety, Comfort and Physiological Parameters

December 28, 2024 updated by: Emine Özge AVCI, TC Erciyes University

The Effect of Stress Ball Used During Intra Uterine Insemination on Pain, Anxiety, Comfort and Physiological Parameters: A Randomized Controlled Study

This study aimed to determine the effects of holding the patient's hand and using a stress ball during the Intrauterine Insemination procedure on pain, anxiety, comfort, and physiological parameters. This study will be conducted as a randomized controlled trial with a pre-test-post-test procedure in the IVF Unit of a Medical Faculty Hospital in Turkey. The study sample was planned to include 120 participants, 40 women each in the stress ball, hand-holding, and control groups. Data will be collected using the Personal Information Form, Visual Analog Scale, State Anxiety Inventory, and General Comfort Scale Short Form. In the Stress Ball Group, participants are given a colored silicone stress ball (5-7 cm diameter) 5 minutes before the procedure. During the procedure, they are instructed to squeeze the ball twice after counting to 10 and repeat this until the procedure is complete. In the Hand-Holding Group, the researcher holds one of the participant's hands during catheter insertion and removal. The researcher's fingers are closed but not interlocked and placed gently on the participant's hand without additional movements or gloves. In the Control Group, Participants receive no additional intervention beyond the standard routine procedures.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Infertility is a significant social and health issue, negatively affecting couples, particularly women's biological, physical, and psychosocial well-being. Assisted reproductive techniques are utilized to help couples with infertility achieve parenthood (Taşkın, 2023). Among these techniques, the Intrauterine Insemination (IUI) procedure can lead to pain, anxiety, discomfort, and trauma, both from the procedure itself and from the emotional impact of infertility. Pain associated with trauma and anxiety may trigger adverse effects, such as increased catecholamine levels, reduced heart rate, blood pressure, and lung vital capacity, due to the activation of the sympathetic nervous system (Yıldız Fındık and Soydaş Yeşilyurt, 2017; Vaajoki et al., 2012).

To alleviate acute pain and enhance comfort during IUI procedures, in addition to medical interventions, non-pharmacological methods with minimal side effects are also critical (Stewart and Cox-Davenport, 2015). One such approach is the attention distribution method, which enables brain receptors to shift focus away from painful stimuli, thereby reducing pain perception and improving control (Elmali and Balcı Akpinar, 2017). The use of stress balls as a non-pharmacological method of attention distribution is particularly noteworthy. Stress balls are accessible, cost-effective, and safe. Furthermore, their use offers a holistic approach, incorporating touch, healing, and therapeutic effects (Yanes et al., 2018). A review of the literature reveals various findings on the psychometric and vital sign changes-such as anxiety, stress, comfort, and compliance-associated with stress ball use during medical procedures, including colonoscopy, endoscopy, extracorporeal shock wave lithotripsy (ESWL), prostate biopsy, radiography, hemodialysis, intravenous (IV) procedures, and polymerase chain reaction (PCR) testing (Apaydin Cirik et al., 2023; Çakır and Evirgen, 2023; Özen et al., 2023; Karataş and Gezginci, 2023, 2022; Gezginci et al., 2018a; Karataş and Gezginci, 2018; Quan et al., 2016). Additionally, some studies highlight the therapeutic or healing benefits of touch in children and intensive care settings (Garrett and Riou, 2021). However, the specific effects of hand-holding and stress ball use on pain, anxiety, comfort, and physiological parameters during the IUI procedure have not yet been thoroughly investigated.

Study Type

Interventional

Enrollment (Estimated)

120

Phase

  • 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 Contact

Study Locations

  • Turkey
    • Melikgazi
      • Kayseri, Melikgazi, Turkey, 38039
        • Recruiting
        • Erciyes University Medical Faculty Hospital IVF Unit
        • Contact:
        • Sub-Investigator:
          • Evrim BAYRAKTAR, Doç. Dr.
        • Sub-Investigator:
          • Gökhan AÇMAZ, Prof. Dr.
        • Principal Investigator:
          • Hümeyra TÜLEK DENİZ, Lecturer
        • Sub-Investigator:
          • Özge AVCI, MSc, Nurse

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

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

Intervention Group 1 (Stress Ball Group)

  1. Agreeing to participate in the study with verbal and written consent,
  2. Being between the ages of 18-50,
  3. Being able to read and write in Turkish,
  4. Not having a muscle or joint problem that prevents squeezing the stress ball
  5. Having Intrauterine Insemination (insemination) as an infertility treatment,

Intervention Group 2 (Hand Holding Group)

  1. Agreeing to participate in the study with verbal and written consent,
  2. Being between the ages of 18-50,
  3. Being able to read and write in Turkish,
  4. Not having a problem with holding hands
  5. Having Intrauterine Insemination (insemination) as an infertility treatment,

Control Group

  1. Agreeing to participate in the study with verbal and written consent,
  2. Being between the ages of 18-50,
  3. Being able to read and write in Turkish,
  4. Having Intrauterine Insemination (insemination) as an infertility treatment, To have an insemination (vaccination) procedure,

Exclusion Criteria:

Intervention Group (Stress Ball Group)

  1. Use any analgesic agent at least 24 hours before the procedure,
  2. Having a chronic pain disorder,
  3. Abandoning the completion of the data collection forms,
  4. Needing urgent intervention by a physician during or immediately after the procedure,
  5. Having any psychiatric disease,
  6. Having a visual, hearing, speech, physical or mental disability,
  7. Wanting to leave the study at any stage,
  8. Not applying the stress ball application as requested

Intervention Group (Hand Holding Group)

  1. Use any analgesic agent at least 24 hours before the procedure,
  2. Having a chronic pain disorder,
  3. Being uncomfortable with the hand-holding application,
  4. Abandoning the completion of the data collection forms,
  5. Needing urgent intervention by a physician during or immediately after the procedure,
  6. Having any psychiatric disease,
  7. Having visual, hearing, speech, having a physical or mental disability,
  8. Wanting to leave the study at any stage,

Control Group

  1. Use any analgesic agent at least 24 hours before the procedure,
  2. Having a chronic pain disorder,
  3. Stopping the completion of the data collection forms,
  4. Needing urgent intervention by a physician during or immediately after the procedure,
  5. Having any psychiatric disease,
  6. Having a visual, hearing, speech, physical or mental disability,
  7. Wanting to leave the study at any stage,

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: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Stress Ball Group
Participants are given a colored silicone stress ball (5-7 cm diameter) 5 minutes before the procedure. During the procedure, they are instructed to squeeze the ball twice after counting to 10 and repeat this until the procedure is complete.
Behavioral: Stress Ball Group
Participants are given a colored silicone stress ball (5-7 cm diameter) 5 minutes before the procedure. During the procedure, they are instructed to squeeze the ball twice after counting to 10 and repeat this until the procedure is complete.
Experimental: Hand Holding/ Therapeutic Touch Group
The researcher holds one of the participant's hands during catheter insertion and removal. The researcher's fingers are closed but not interlocked and placed gently on the participant's hand without additional movements or gloves.
Behavioral: Hand-Holding Group
The researcher holds one of the participant's hands during catheter insertion and removal. The researcher's fingers are closed but not interlocked and placed gently on the participant's hand without additional movements or gloves.
No Intervention: Control Group
Participants receive no additional intervention beyond the standard routine procedures.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Personal Information Form
Time Frame: The researcher will apply 10 minutes before the IUI procedure and 15 minutes after the procedure to women who are kept under observation in the patient monitoring room after the IUI procedure.
This form, which includes the characteristics of the patients, consists of 10 questions, including age, education level, marital status, employment status, income level, type of infertility, duration of infertility problem, and cause of infertility. The patient's physiological parameters (pulse, respiration, systolic blood pressure (SBP), diastolic blood pressure (DBP), and oxygen saturation values (SpO2) before and after the procedure will also be recorded using this form.
The researcher will apply 10 minutes before the IUI procedure and 15 minutes after the procedure to women who are kept under observation in the patient monitoring room after the IUI procedure.
Visual Analog Scale
Time Frame: The researcher will apply 10 minutes before the IUI procedure and 15 minutes after the procedure to women who are kept under observation in the patient monitoring room after the IUI procedure.
It will be used to determine the pain intensity experienced by infertile women during IUI. The pain level varies between 0-10, and the increase in the marked numerical value indicates an increase in the pain level. In the VAS evaluation, 0=no pain, 1-4=mild pain, 5-6=moderate pain, and 7-10=severe pain (Zielinski et al., 2020).
The researcher will apply 10 minutes before the IUI procedure and 15 minutes after the procedure to women who are kept under observation in the patient monitoring room after the IUI procedure.
State Anxiety Inventory
Time Frame: The researcher will apply 10 minutes before the IUI procedure and 15 minutes after the procedure to women who are kept under observation in the patient monitoring room after the IUI procedure.
The scale Spielberger et al. (1970) developed to measure the individual's state and trait anxiety level, reliability, and validity in Turkish was conducted by Öner and Le Compte (1983). The scale measures anxiety. It consists of two sub-units that are measured separately: state anxiety requires the individual to describe how they feel at a certain moment and under certain conditions, and trait anxiety requires the individual to describe how they generally feel. In this study, the state anxiety scale will be used since the anxiety that the individual feels indirectly from the stressful situation they are in will be evaluated. The total score obtained from the scale varies between 20 and 80, with a high score indicating a high level of anxiety.
The researcher will apply 10 minutes before the IUI procedure and 15 minutes after the procedure to women who are kept under observation in the patient monitoring room after the IUI procedure.
General Comfort Scale Short Form
Time Frame: The researcher will apply 10 minutes before the IUI procedure and 15 minutes after the procedure to women who are kept under observation in the patient monitoring room after the IUI procedure.
The Kolcaba (2006) scale was developed to measure patients' comfort. The scale consists of 28 items in 6-point Likert type in 3 sub-dimensions: relief (9), relaxation (9), and overcoming problems sub-dimension (10 items). The highest total score from the scale is 168 points; the lowest total score is 28 points (Çıtlık et al., 2018)
The researcher will apply 10 minutes before the IUI procedure and 15 minutes after the procedure to women who are kept under observation in the patient monitoring room after the IUI procedure.

Collaborators and Investigators

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

Sponsor

TC Erciyes University

Investigators

  • Principal Investigator: Hümeyra TÜLEK DENİZ, MSc, Kafkas Üniversity

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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)

October 1, 2024

Primary Completion (Estimated)

March 1, 2025

Study Completion (Estimated)

June 30, 2025

Study Registration Dates

First Submitted

December 28, 2024

First Submitted That Met QC Criteria

December 28, 2024

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

December 28, 2024

Last Verified

December 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2024/148
  • Erciyes University (Other Identifier: Erciyes University)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

There has been no planning on this matter.

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.

Clinical Trials on Infertility, Female

Clinical Trials on Stress Ball Group

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Bosnia & Herzegovina

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe