Clinical Trial Details
— Status: Recruiting
Administrative data
| NCT number |
NCT06436859 |
| Other study ID # |
Hayatoktem03 |
| Secondary ID |
|
| Status |
Recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
May 15, 2024 |
| Est. completion date |
May 15, 2025 |
Study information
| Verified date |
May 2024 |
| Source |
Gulhane School of Medicine |
| Contact |
Meltem UGURLU, associate professor |
| Phone |
05555807841 |
| Email |
meltemugurlu17[@]gmail.com |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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.
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.
