Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT06421233
Other study ID # 2023/516
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date September 4, 2023
Est. completion date November 30, 2023

Study information

Verified date May 2024
Source TC Erciyes University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The postpartum period, especially in the first few weeks, can be a difficult period for mothers to adapt to the new situation of having a baby. During this process, physiological, psychological and social changes occur in the mother's body. While many mothers adapt to these changes easily, some mothers may experience psychological disorders at different levels.Among these, anxiety and depression are the most common diseases. Anxiety can negatively affect mothers, especially during birth and the postpartum period.During the postpartum period, nurses have the opportunity to improve maternal and infant health by recognizing and treating anxiety.Physical symptoms associated with postpartum anxiety include fatigue, irritability, difficulty concentrating, and sleep disturbances. However, during the vaginal birth process, mothers may feel tired in the early postpartum period, as the pregnant woman spends a lot of energy by staying hungry for a long time. When the literature was examined, it was determined that endorphin massage reduces back pain in pregnant women, reduces anxiety level in pregnant women, accelerates the involution process in the postpartum period, and has positive effects on postpartum depression.Similar to endorphin massage, it has been determined that back massage reduces back pain in the postpartum period and provides the mother with both physiological and psychological relief. In addition, no study has been found examining the effect of endorphin massage applied to postpartum women on anxiety levels and fatigue in the postpartum period. Therefore, this study aimed to determine the effect of endorphin massage applied to postpartum women who gave birth vaginally on postpartum anxiety and fatigue levels.


Description:

Birth is a very important experience in a woman's life. The postpartum period is a period of 6-8 weeks after birth. During this process, physiological, psychological and social changes occur in the puerperal woman's body. While many postpartum women easily adapt to these changes, some postpartum women may experience psychological disorders at different levels. Anxiety can negatively affect postpartum women, especially during birth and the postpartum period. Although it is generally desirable to experience anxiety at a normal and mild level, excessive anxiety can tire the individual emotionally.In addition, postpartum women may feel tired in the early postpartum period due to the pregnant woman fasting for a long time and spending too much energy during the vaginal birth process.This situation can be caused by many physical, psychological and situational factors. Postpartum fatigue can lead to deterioration in the general health of the mother and her baby, as well as other serious problems.Postpartum fatigue negatively affects women's physical and mental functions, wound healing, self-care skills and behaviors, energy, motivation and cognitive status, adaptation to motherhood, baby care behaviors, relationships with marriage and family members, including sexuality, work performance and quality of life. is a symptom.In this process, applications applied to postpartum women increase the quality of life by reducing fatigue.Endorphin massage is among the practices performed to improve the quality of life of women during the postpartum period. Endorphin is a natural painkiller known as the happiness hormone, which is similar to opioids secreted by the body, reduces pain, provides relaxation, protects the body against infections, accelerates metabolism. It is known that massage increases endorphin levels by having a relaxing effect on the muscles. Endorphin massage increases the release of endorphins, allowing the individual to relax, relaxing the muscles and reducing pain. Endorphin massage is a light massage technique that can increase the release of oxytocin and endorphin hormones and provide a feeling of calmness and comfort. When the literature was examined, it was determined that endorphin massage reduces back pain in pregnant women, reduces anxiety level in pregnant women, accelerates the involution process in the postpartum period, and has positive effects on postpartum depression.Similar to endorphin massage, it has been determined that back massage reduces back pain in the postpartum period and provides the mother with both physiological and psychological relief. In addition, no study has been found examining the effect of endorphin massage applied to postpartum women on anxiety levels and fatigue in the postpartum period. Therefore, this study aimed to determine the effect of endorphin massage applied to postpartum women who gave birth vaginally on postpartum anxiety and fatigue levels.


Recruitment information / eligibility

Status Completed
Enrollment 50
Est. completion date November 30, 2023
Est. primary completion date November 30, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 19 Years to 40 Years
Eligibility Inclusion Criteria: - Giving birth vaginally at term, - Postpartum within 24 hours, - Primiparous, - Those who are healthy and have given birth to a single baby, - Postpartum women who volunteered to participate in the study were included. Exclusion Criteria: - Those with psychiatric illness (Bipolar Disorder, Depression, Obsessive Compulsive Disorder), - People with chronic diseases (Heart disease, Thyroid problems, Diabetes mellitus, Hypertension, asthma, COPD, - Those who have been diagnosed with a risky pregnancy (Pre-eclampsia, Arthritis, Pregnancy-related hypertension, Gestational diabetes), - Whose baby was admitted to neonatal intensive care, - Postpartum women with postpartum bleeding were not included in the study.

Study Design


Related Conditions & MeSH terms


Intervention

Other:
massage
Endorphin massage will be given for 15 minutes every 2 hours.

Locations

Country Name City State
Turkey Kayseri City Hospital Kocasinan Kayseri

Sponsors (1)

Lead Sponsor Collaborator
TC Erciyes University

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary State and Trait Anxiety Scale The state anxiety scale determines how the individual feels at a certain moment and under certain conditions. The scale consists of 20 questions and is asked to choose one of the options 'not at all', 'somewhat', 'a lot' and 'completely' depending on the severity of the thoughts or behaviors. The trait anxiety scale determines how the individual feels, regardless of the situation and conditions, and consists of 20 questions. In answering this scale, one is asked to choose one of the following options: 'almost never', 'sometimes', 'most of the time' and 'almost always', depending on the frequency of the thoughts or behaviors. It was applied twice in total, two hours apart.
Secondary Visual Similarity Scale for Fatigue The scale has sub-dimensions of fatigue and energy . It consists of a total of 18 items in two sub-dimensions.
The scale consists of 10 cm horizontal lines with positive expressions at one end and negative expressions at the other end of each item. While the items of the fatigue sub-dimension progress from positive to negative expressions, the items of the energy sub-dimension are in the opposite order. The lowest score obtained in the fatigue sub-dimension is zero and the highest score is 130. In the energy sub-dimension, scores are calculated between 0 and 50 points. A high score of the fatigue sub-dimension and a low score of the energy sub-dimension indicate that the severity of fatigue increases.
It was applied twice in total, two hours apart.
See also
  Status Clinical Trial Phase
Active, not recruiting NCT05777044 - The Effect of Hatha Yoga on Mental Health N/A
Recruiting NCT04680611 - Severe Asthma, MepolizumaB and Affect: SAMBA Study
Completed NCT04512768 - Treating Comorbid Insomnia in Transdiagnostic Internet-Delivered Cognitive Behaviour Therapy N/A
Completed NCT04748367 - Leveraging on Immersive Virtual Reality to Reduce Pain and Anxiety in Children During Immunization in Primary Care N/A
Recruiting NCT05563805 - Exploring Virtual Reality Adventure Training Exergaming N/A
Completed NCT04579354 - Virtual Reality (VR) Tour to Reduce Preoperative Anxiety Before Anaesthesia N/A
Completed NCT03535805 - Transdiagnostic, Cognitive and Behavioral Intervention for in School-aged Children With Emotional and Behavioral Disturbances N/A
Completed NCT03457714 - Guided Internet Delivered Cognitive-Behaviour Therapy for Persons With Spinal Cord Injury: A Feasibility Trial
Recruiting NCT05956912 - Implementing Group Metacognitive Therapy in Cardiac Rehabilitation Services (PATHWAY-Beacons)
Active, not recruiting NCT05302167 - Molehill Mountain Feasibility Study. N/A
Completed NCT05881681 - A Mindfulness Approach to UA for Afro-descendants N/A
Completed NCT05588622 - Meru Health Program for Cancer Patients With Depression and Anxiety N/A
Active, not recruiting NCT04961112 - Evaluating the Efficacy of Cranial Electrotherapy Stimulation in Mitigating Anxiety-induced Cognitive Deficits N/A
Completed NCT05980845 - The Effect Nature Sounds and Music on Hemodialysis Patients N/A
Terminated NCT04612491 - Pre-operative Consultation on Patient Anxiety and First-time Mohs Micrographic Surgery
Recruiting NCT05449002 - Digital Single Session Intervention for Youth Mental Health N/A
Completed NCT05585749 - Virtual Reality Application on Pain Intensity and Anxiety Level in Endoscopy Patients N/A
Terminated NCT03272555 - WILD 5 Wellness: A 30-Day Intervention N/A
Recruiting NCT05997849 - Development of a Multiplatform Mental Health Mobile Tool N/A
Active, not recruiting NCT03613155 - Assessment of Anxiety in Patients Treated by SMUR Toulouse and Receiving MEOPA as Part of Their Care