## Protocol Section
### Identification Module
**NCT ID:** NCT06436859

**Brief Title:** The Effect of Stress Ball on Labor Pain, Anxiety and Satisfaction in Labor

**Official Title:** Phd Student Msc Midwifery Öznur HAYAT ÖKTEM

#### Organization Study ID Info
**ID:** Hayatoktem03
#### Organization
**Class:** OTHER
**Full Name:** Gulhane School of Medicine
### Status Module
#### Completion Date
**Date:** 2025-05-15

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-31

**Type:** ESTIMATED

**Last Update Submit Date:** 2024-05-28

**Overall Status:** RECRUITING

#### Primary Completion Date
**Date:** 2025-05-15

**Type:** ESTIMATED

#### Start Date
**Date:** 2024-05-15

**Type:** ACTUAL

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-31
**Type:** ESTIMATED
**Study First Submit Date:** 2024-05-15
**Study First Submit QC Date:** 2024-05-28
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** Öznur Hayat Öktem

#### Responsible Party

**Investigator Affiliation:** Gulhane School of Medicine

**Investigator Full Name:** Öznur Hayat Öktem

**Investigator Title:** PhD student

**Type:** SPONSOR_INVESTIGATOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** False

### Description Module

**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.

**Detailed Description:** Birth is accepted as one of the physiological behaviors that have existed since the beginning of mankind and whose formation cycle has not changed. Birth is a health condition that many women desire at some point in their lives. While birth is a normal physiological process and should be an important tool for happiness, it also carries risks such as pain, suffering and discomfort. For this reason, one of the first thoughts a pregnant woman has about childbirth is labor pain. Birth pain is a central and universal part of a woman birth experience.Causes of labor pain include psychological factors such as fear and anxiety, previous experiences, birth environment, lack of information and inadequate support, as well as physical causes such as uterine contractions, cervical dilatation and effacement. Anxiety and tension experienced by pregnant women during the labor process can slow down the progress of labor. Anxiety also reduces women self-confidence, and pregnant women perceive themselves as inadequate and incompetent. Anxiety experienced during labor leads women to cesarean section at their own request.

Utilizing non-pharmacologic and supportive methods to reduce labor pain is an important part of nursing/midwifery practices. Providing alternatives that allow women to make active decision-making to reduce pain management and anxiety during labor may affect pain, anxiety and hormonal oscillations. Currently, alternative strategies to reduce the use of medication during labor are being considered.

In line with the results of this study, it is thought that the stress ball may be effective in labor, where anxiety and pain are frequently experienced.

After obtaining all official permissions, it is planned to collect the data face-to-face. In the data collection phase, the researcher will first explain the purpose of the study to the women who meet the inclusion criteria and inform them about the study through written consent of the women will be obtained. When the women in the control and experimental groups are admitted to the delivery room, the Introductory Information ; will be collected by the researcher by face-to-face interview method. In addition,;State Anxiety Scale; will be administered during the first admission, VAS before cervical dilatation 0-3 cm, 3-8 cm and 8-10 cm and before placenta emergence, and ;State Anxiety Scale; will be administered when dilatation is 0-3 and 3-8 cm (at the beginning and end of the active phase of labor).;Birth Satisfaction Scale; will be administered in the first 24 hours after delivery before the patient is discharged. Data collection will be done similarly in both groups.

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

### Conditions Module

**Conditions:**

- Pregnancy

- Labor

**Keywords:**

- Stress ball

- labor pain

- anxiety

- satisfaction

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** SINGLE

**Who Masked:**

- PARTICIPANT

**Primary Purpose:** SUPPORTIVE_CARE

#### Enrollment Info

**Count:** 48

**Type:** ESTIMATED

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** Stress ball group

**Intervention Names:**

- Behavioral: stress ball group

**Label:** Experiment

**Type:** EXPERIMENTAL

#### Arm Group 2

**Description:** Routine care

**Label:** Control group

**Type:** NO_INTERVENTION

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Experiment

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

**Name:** stress ball group

**Type:** BEHAVIORAL

### Outcomes Module

#### Primary Outcomes

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

**Measure:** Labor pain

**Time Frame:** 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.

**Description:** The state anxiety scale will be filled for anxiety .

**Measure:** Anxiety

**Time Frame:** 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.

**Description:** 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.

**Measure:** Birth satisfaction status

**Time Frame:** This form will be administered in the first 24 hours after delivery before discharge.

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

**Gender Based:** True

**Healthy Volunteers:** True

**Maximum Age:** 35 Years

**Minimum Age:** 18 Years

**Sex:** FEMALE

**Standard Ages:**

- ADULT

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** meltemugurlu17@gmail.com

**Name:** Meltem UĞURLU, associate professor

**Phone:** 05555807841

**Role:** CONTACT

#### Locations

**Location 1:**

**City:** Karabük

**Contacts:**

***Contact 1:***

- **Email:** oznurhayat_78@hotmail.com

- **Name:** PhD student Öznur HAYAT ÖKTEM, Phd Student Msc Midwife

- **Phone:** +905053202563

- **Role:** CONTACT

**Country:** Turkey

**Facility:** Karabuk Training and Research Hospital, obstetrics clinic

**Status:** RECRUITING

**Zip:** 78100

### IPD Sharing Statement Module

**IPD Sharing:** NO

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000010146

- Term: Pain

- ID: D000009461

- Term: Neurologic Manifestations

### Condition Browse Module - Browse Branches

- Abbrev: BXM

- Name: Behaviors and Mental Disorders

- Abbrev: All

- Name: All Conditions

- Abbrev: BC23

- Name: Symptoms and General Pathology

- Abbrev: BC10

- Name: Nervous System Diseases

### Condition Browse Module - Browse Leaves

- ID: M4324

- Name: Anxiety Disorders

- Relevance: LOW

- As Found: Unknown

- ID: M26008

- Name: Labor Pain

- Relevance: HIGH

- As Found: Labor Pain

- ID: M13066

- Name: Pain

- Relevance: LOW

- As Found: Unknown

- ID: M12404

- Name: Neurologic Manifestations

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000048949

- Term: Labor Pain

### Misc Info Module

- Version Holder: 2024-05-31
