Non-pharmacolytic Method in Obese; Pain and Anxiety

NCT05738551 | Completed DMC

• 1 other identifier: HİLAL
• Study Type: interventional
• Target: 108
• Locations: 1 country
• Sites: 1

Brief Summary

Access to the vascular access is difficult in obese patients. Therefore, vascular access can be challenging and worrying for obese individuals. This strain causes pain and anxiety. Different interventions can be applied to reduce the pain and anxiety felt. One of them is the methods of distraction. Among these methods, chewing gum and using a stress ball can contribute positively to the pain and anxiety at the entrance to the vein in order to draw blood in obese individuals. In addition, these interventions may affect vital parameters. It was aimed to evaluate the effects of chewing gum and using a stress ball during vascular access in obese individuals on pain level, anxiety level and vital signs

Conditions

Obesity

Keywords

obesity; pain; anxiety; vascular access

Outcome Measures

Primary Outcomes (1)

• pain severity

  The patient will be asked to evaluate the pain felt by the VAS pain scale.

  within 5 minutes after procedure

Secondary Outcomes (1)

• Anxiety state

  within 5 minutes after procedure

Other Outcomes (3)

• Arterial blood pressure value

  within 5 minutes after procedure

• Heart rate value

  "within 5 minutes after procedure

• Oxygen saturation valu

  within 5 minutes after procedure

Study Arms (3)

STRESS BALL

EXPERIMENTAL

Starting 5 minutes before the access to the vascular access, the patient will be asked to squeeze the stress ball in the palm until the blood collection is completed.

Other: stress ball

CHEWİNG GUM

EXPERIMENTAL

Starting 5 minutes before the vascular access, the patient will be allowed to chew gum until the blood collection is completed.

Other: chewing gum

ROUTINE APPLICATION

NO INTERVENTION

Only within the scope of routine practice of the patient, vascular access will be provided and the blood collection process will be completed.

Interventions

stress ball OTHER

Applicable to group 1

STRESS BALL

chewing gum OTHER

Applicable to group 2

CHEWİNG GUM

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Being over 18 years old
• Having a body mass index of 30 and above
• Giving blood for analyzes upon the request of the physician
• Having the harmony of place and time
• Willingness to participate in the research

You may not qualify if:

• Absence of vision and hearing problems
• Presence of any disease that may affect pain perception
• Having cognitive problems
• Having a condition that prevents chewing gum
• Having a condition that prevents him from using the stress ball

Sponsors & Collaborators

• Necmettin Erbakan University: lead

Study Sites (1)

Necmettin Erbakan Univercity

Konya, 42370, Turkey (Türkiye)

Location

Related Publications (5)

• Weijenberg RA, Lobbezoo F. Chew the Pain Away: Oral Habits to Cope with Pain and Stress and to Stimulate Cognition. Biomed Res Int. 2015;2015:149431. doi: 10.1155/2015/149431. Epub 2015 May 18.

  PMID: 26090381 BACKGROUND

• Kabore RAF, Traore IA, Traore SIS, Bougouma CTHW, Augustin P, Ouro-Bang'na Maman AF. Broken needle during spinal anesthesia: an avoidable complication. Local Reg Anesth. 2018 Nov 23;11:111-113. doi: 10.2147/LRA.S175547. eCollection 2018.

  PMID: 30538540 RESULT

• Rodriguez-Calero MA, Blanco-Mavillard I, Morales-Asencio JM, Fernandez-Fernandez I, Castro-Sanchez E, de Pedro-Gomez JE. Defining risk factors associated with difficult peripheral venous Cannulation: A systematic review and meta-analysis. Heart Lung. 2020 May-Jun;49(3):273-286. doi: 10.1016/j.hrtlng.2020.01.009. Epub 2020 Feb 11.

  PMID: 32057426 RESULT

• Dat M, Jc TM, Ac N, Reis RK, Mh B, Sem T. Prevalence of and factors associated with difficult peripheral venipuncture in adult surgical patients. J Vasc Access. 2021 May;22(3):404-410. doi: 10.1177/1129729820939335. Epub 2020 Jul 28.

  PMID: 32720556 RESULT

• Turkben Polat H, Burucu R. Effects of chewing gum and stress ball on pain and anxiety during blood collection in people with obesity: a randomized controlled study. Psychol Health Med. 2025 Nov 12:1-13. doi: 10.1080/13548506.2025.2587975. Online ahead of print.

  PMID: 41222481 DERIVED

MeSH Terms

Conditions

Obesity; Pain; Anxiety Disorders

Interventions

Chewing Gum

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neurologic Manifestations; Mental Disorders

Intervention Hierarchy (Ancestors)

Plant Gums; Biopolymers; Polymers; Macromolecular Substances; Polysaccharides; Carbohydrates; Plant Exudates; Biological Products; Complex Mixtures; Candy; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

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: Assit. Prof.

Model Details: Three-arm randomized controlled trial

Study Record Dates

• First Submitted: January 23, 2023
• First Posted: February 22, 2023
• Study Start: February 15, 2023
• Primary Completion: March 15, 2023
• Study Completion: March 30, 2023
• Last Updated: June 4, 2024

Record last verified: 2024-06

Locations

TU (1)