The Effect of Stress Ball on Labor Pain, Anxiety and Satisfaction in Labor

NCT06436859 | Recruiting

• 1 other identifier: Hayatoktem03
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this study was to determine the effect of stress ball use during labor on labor pain, anxiety and satisfaction levels in women admitted to Karabük Training and Research Hospital for delivery. H1 Using the Stress Ball in Labor reduces labor pain. H2 Using the Stress Ball in Labor Reduces Anxiety H3 Use of Stress Ball in Labor increases labor satisfaction.

Conditions

Pregnancy; Labor

Keywords

Stress ball; labor pain; anxiety; satisfaction

Outcome Measures

Primary Outcomes (3)

• Labor pain

  The pregnant woman's pain will be evaluated with VAS.

  Vaginal examination is 0-3 cm in the latent phase, 3-8 cm in the active phase, 8-10 cm in the transitional phase and will be measured with VAS at the end of the second phase and before placenta separation.

• Anxiety

  The state anxiety scale will be filled for anxiety .

  State anxiety scale will be administered in the latent phase before the stress ball is applied and at 8 cm after the stress ball is applied.

• Birth satisfaction status

  A minimum of 30 and a maximum of 150 points can be obtained from the scale. The higher the score, the higher the level of satisfaction.

  This form will be administered in the first 24 hours after delivery before discharge.

Study Arms (2)

Experiment

EXPERIMENTAL

Stress ball group

Behavioral: stress ball group

Control group

NO INTERVENTION

Routine care

Interventions

stress ball group BEHAVIORAL

According to randomization, pregnant women in the intervention group will receive "stress ball therapy" during labor.

Experiment

Eligibility Criteria

• Age: 18 Years - 35 Years
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Being at 38 weeks or more of pregnancy,
• Having a single, healthy fetus in head position,
• Applying during the latent phase of labor (cervical dilatation between 0-3 cm), .To give birth vaginally.

You may not qualify if:

• Having become pregnant through assisted reproductive techniques,
• Having a gestational or chronic disease,
• Having an obstacle to giving birth vaginally,
• Suspicion of fetal anomaly,
• Not volunteering to work,
• Women under the age of 18,
• Women who are illiterate in Turkish,
• Decision to perform caesarean section during labor,
• The participant wishes to withdraw from the research,
• Development of fetal distress,
• Using vacuum or forceps during birth, .Women with vision, hearing or mental problems.

Sponsors & Collaborators

• Öznur Hayat Öktem: lead

Study Sites (1)

Karabuk Training and Research Hospital, obstetrics clinic

Karabük, 78100, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Labor Pain; Anxiety Disorders; Personal Satisfaction

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mental Disorders; Behavior

Central Study Contacts

Meltem UĞURLU, associate professor

CONTACT

05555807841; meltemugurlu17@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: PhD student

Study Record Dates

• First Submitted: May 15, 2024
• First Posted: May 31, 2024
• Study Start: May 15, 2024
• Primary Completion: May 15, 2025
• Study Completion: May 15, 2025
• Last Updated: May 31, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)