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

NCT06759337 | Recruiting DMC

• 2 other identifiers: 2024/148Erciyes University
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Infertility Assisted Reproductive Technology; Infertility, Female

Keywords

Assisted Reproductive Techniques; Stress Ball; Pain; Anxiety; Comfort; Physiological Parameters; infertility

Outcome Measures

Primary Outcomes (4)

• Personal Information Form

  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

  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

  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

  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.

Study Arms (3)

Stress Ball Group

EXPERIMENTAL

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

Hand Holding/ Therapeutic Touch Group

EXPERIMENTAL

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

Control Group

NO INTERVENTION

Participants receive no additional intervention beyond the standard routine procedures.

Interventions

Stress Ball Group BEHAVIORAL

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.

Stress Ball Group

Hand-Holding Group BEHAVIORAL

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.

Hand Holding/ Therapeutic Touch Group

Eligibility Criteria

• Age: 18 Years - 50 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Intervention Group 1 (Stress Ball Group)
• Agreeing to participate in the study with verbal and written consent,
• Being between the ages of 18-50,
• Being able to read and write in Turkish,
• Not having a muscle or joint problem that prevents squeezing the stress ball
• Having Intrauterine Insemination (insemination) as an infertility treatment,
• Intervention Group 2 (Hand Holding Group)
• Agreeing to participate in the study with verbal and written consent,
• Being between the ages of 18-50,
• Being able to read and write in Turkish,
• Not having a problem with holding hands
• Having Intrauterine Insemination (insemination) as an infertility treatment,
• Control Group
• Agreeing to participate in the study with verbal and written consent,
• Being between the ages of 18-50,

You may not qualify if:

• Intervention Group (Stress Ball Group)
• Use any analgesic agent at least 24 hours before the procedure,
• Having a chronic pain disorder,
• Abandoning the completion of the data collection forms,
• Needing urgent intervention by a physician during or immediately after the procedure,
• Having any psychiatric disease,
• Having a visual, hearing, speech, physical or mental disability,
• Wanting to leave the study at any stage,
• Not applying the stress ball application as requested
• Intervention Group (Hand Holding Group)
• Use any analgesic agent at least 24 hours before the procedure,
• Having a chronic pain disorder,
• Being uncomfortable with the hand-holding application,
• Abandoning the completion of the data collection forms,
• Needing urgent intervention by a physician during or immediately after the procedure,

Sponsors & Collaborators

• TC Erciyes University: lead

Study Sites (1)

Erciyes University Medical Faculty Hospital IVF Unit

Kayseri, Melikgazi, 38039, Turkey (Türkiye)

RECRUITING

Related Publications (17)

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• Garrett B, Riou M. A rapid evidence assessment of recent therapeutic touch research. Nurs Open. 2021 Sep;8(5):2318-2330. doi: 10.1002/nop2.841. Epub 2021 Mar 20.

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• Genc H, Korkmaz M, Akkurt A. The Effect of Virtual Reality Glasses and Stress Balls on Pain and Vital Findings During Transrectal Prostate Biopsy: A Randomized Controlled Trial. J Perianesth Nurs. 2022 Jun;37(3):344-350. doi: 10.1016/j.jopan.2021.09.006. Epub 2022 Apr 7.

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• Gezginci E, Iyigun E, Yalcin S, Bedir S, Ozgok IY. Comparison of Two Different Distraction Methods Affecting the Level of Pain and Anxiety during Extracorporeal Shock Wave Lithotripsy: A Randomized Controlled Trial. Pain Manag Nurs. 2018 Jun;19(3):295-302. doi: 10.1016/j.pmn.2017.09.005. Epub 2017 Dec 14.

  PMID: 29248604 BACKGROUND

• Karatas TC, Gezginci E. The Effect of Using a Stress Ball During Endoscopy on Pain, Anxiety, and Satisfaction: A Randomized Controlled Trial. Gastroenterol Nurs. 2023 Jul-Aug 01;46(4):309-317. doi: 10.1097/SGA.0000000000000739. Epub 2023 May 17.

  PMID: 37199436 BACKGROUND

• Ozen N, Berse S, Tosun B. Effects of using a stress ball on anxiety and depression in patients undergoing hemodialysis: A prospective, balanced, single-blind, crossover study. Hemodial Int. 2023 Oct;27(4):411-418. doi: 10.1111/hdi.13102. Epub 2023 Jun 15.

  PMID: 37318078 BACKGROUND

• Sadeghi T, Mohammadi N, Shamshiri M, Bagherzadeh R, Hossinkhani N. Effect of distraction on children's pain during intravenous catheter insertion. J Spec Pediatr Nurs. 2013 Apr;18(2):109-14. doi: 10.1111/jspn.12018. Epub 2013 Mar 5.

  PMID: 23560582 BACKGROUND

• Shekhar S, Suprabha BS, Shenoy R, Rao A, Rao A. Effect of active and passive distraction techniques while administering local anaesthesia on the dental anxiety, behaviour and pain levels of children: a randomised controlled trial. Eur Arch Paediatr Dent. 2022 Jun;23(3):417-427. doi: 10.1007/s40368-022-00698-7. Epub 2022 Mar 10.

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• Quan X, Joseph A, Nanda U, Moyano-Smith O, Kanakri S, Ancheta C, Loveless EA. Improving Pediatric Radiography Patient Stress, Mood, and Parental Satisfaction Through Positive Environmental Distractions: A Randomized Control Trial. J Pediatr Nurs. 2016 Jan-Feb;31(1):e11-22. doi: 10.1016/j.pedn.2015.08.004. Epub 2015 Sep 26.

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• Vaajoki A, Pietila AM, Kankkunen P, Vehvilainen-Julkunen K. Effects of listening to music on pain intensity and pain distress after surgery: an intervention. J Clin Nurs. 2012 Mar;21(5-6):708-17. doi: 10.1111/j.1365-2702.2011.03829.x. Epub 2011 Aug 15.

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• Yanes AF, Weil A, Furlan KC, Poon E, Alam M. Effect of Stress Ball Use or Hand-holding on Anxiety During Skin Cancer Excision: A Randomized Clinical Trial. JAMA Dermatol. 2018 Sep 1;154(9):1045-1049. doi: 10.1001/jamadermatol.2018.1783.

  PMID: 30027283 BACKGROUND

• Yilmaz D, Gunes UY. The effect on pain of three different nonpharmacological methods in peripheral intravenous catheterisation in adults. J Clin Nurs. 2018 Mar;27(5-6):1073-1080. doi: 10.1111/jocn.14133. Epub 2018 Jan 8.

  PMID: 29076581 BACKGROUND

• Zielinski J, Morawska-Kochman M, Zatonski T. Pain assessment and management in children in the postoperative period: A review of the most commonly used postoperative pain assessment tools, new diagnostic methods and the latest guidelines for postoperative pain therapy in children. Adv Clin Exp Med. 2020 Mar;29(3):365-374. doi: 10.17219/acem/112600.

  PMID: 32129952 BACKGROUND

MeSH Terms

Conditions

Infertility, Female; Pain; Anxiety Disorders; Infertility

Condition Hierarchy (Ancestors)

Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mental Disorders

Study Officials

• Hümeyra TÜLEK DENİZ, MSc

  Kafkas University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Hümeyra TÜLEK DENİZ, MSc

CONTACT

+90 474 242 68 40; humeyra.tulek@kafkas.edu.tr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: mSc, nurse

Study Record Dates

• First Submitted: December 28, 2024
• First Posted: January 6, 2025
• Study Start: October 1, 2024
• Primary Completion: March 1, 2025
• Study Completion: June 30, 2025
• Last Updated: January 6, 2025

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)