Ignite Creation Date:
2024-05-06 @ 12:26 PM
Last Modification Date:
2024-10-26 @ 12:58 PM
Study NCT ID:
NCT03755284
Status:
COMPLETED
Last Update Posted:
2018-12-07
First Post:
2018-11-20
Brief Title:
The Effect of Sacral Massage on Labor
Sponsor:
Semra Çevik phD
Organization:
University of Gaziantep
Study Overview
Official Title:
The Effect Of Sacral Massage On Labour Pain and Anxiety A Randomized Controlled Trial
Status:
COMPLETED
Status Verified Date:
2018-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Nonpharmacologic pain control methods which are increasingly becoming widespread in coping with the labour pain are the methods that allow women to completely relax without using any medication and direct them to perceive the pain at the lowest level This study was conducted to determine the effect of sacral massage on labour pain and anxiety This study was conducted as a randomized controlled experimental study at Bağcılar Training and Research Hospital Obstetrics and Gynecology Clinic between March and October 2016
Hypotheses of the Study
1 Massage applied to the sacral region decreases the perception of a womans labour pain
2 Massage applied to the sacral region decreases the womans levels of concern and anxiety about labour
3 Massage applied to the sacral region increases the womans satisfaction with the labour
Hypotheses of the Study
1 Massage applied to the sacral region decreases the perception of a womans labour pain
2 Massage applied to the sacral region decreases the womans levels of concern and anxiety about labour
3 Massage applied to the sacral region increases the womans satisfaction with the labour
Detailed Description:
Study design
This was a randomized and controlled experimental study aimed to determine the effects of sacral massage on labour pain and anxiety
Setting and samples
The study was performed in volunteer pregnant women who applied to xxx Training and Research Hospital Delivery Unit to undergo their first labour between January 25 and October 25 2016 This unit contains 1 delivery room with 2 tables 2 labour follow-up rooms with 5 beds 1 postpartum room with 5 beds and 1 nursing room
According to hospital records in all 342 pregnant women who applied to xxx Training and Research Hospital Delivery Unit to undergo their first labour between January 25 and October 25 2016 constituted the population of the study The following inclusion criteria were used to determine participation in the study 1 19-40-year-old primiparous pregnant women2 Singleton pregnancies between 38-42 weeks 3 Pregnant women whose labour began spontaneously 4 Pregnant women with a healthy foetus 5 Pregnant women without any complications that may cause dystocia during labour 6 Pregnant women for whom analgesia and anaesthesia were not used during the first phase of labour 7 Pregnant women who volunteered to participate in the research and who could establish verbal communication In addition Pregnant women with high-risk pregnancies with caesarean section indication and Pregnant women with a chronic illness were excluded
The sample size was calculated by Medical Faculty Biostatistics Department using Minitab Program The sample volume to represent the population was determined as minimum 30 people for each group when considering comparison results of mean scores in the study of Field with a risk of α 005 an accuracy rate of 1-α 095 and a power ratio of B 020 1-B 080
The study was conducted with two groups namely Massage Group experimental and Control Group 30 pregnant women were included in each group therefore the study was conducted with a total of 60 pregnant women The women who participated in the study were randomized randomly as control double and experimental single groups according to the single or double patient admission numbers The women who participated in the study were randomized into either the control double or the experimental single group according to single or double patient admission numbers
Measurements
In this study the Questionnaire form Birth action follow-up form postpartum interview form Visual analogue scale VAS and State-trait anxiety inventory STAI FORM TX-I were used to collect the data
1 Questionnaire Form Questions that reflect the sociodemographic characteristics of the patients age educational status social security marital status information about pregnancy drugs used status of their willingness to become pregnant gestational week status of attending examinations status of collecting information about labour the methods used to cope with the pain and open-ended questions that evaluate the previous use of massage
2 Birth Action Follow-Up Form The questions that indicate the length of the first phase the interventions performed to shorten the first phase of labour the methods used by the patient to cope with the labour pain the emotional behaviours of the pregnant women during labour the length of the second phase adjustment of the pregnant women the presence of intervention in labour the status of episiotomy the total duration of labour and the babys health
3 Postpartum Interview Form Open and closed questions that indicate the pregnant womens thoughts about labour the status of overall satisfaction with labour and how the women feel were included in this form which was prepared by a researcher in accordance with the relevant literature
4 Visual Analogue Scale VAS The Visual Analogue Scale VAS was used to measure the severity of labour pain On this scale numbers from 0 to 10 appear on a horizontal line of 100 mm The pain level is expressed in figures that range from 0 to 10 as follows the absence of pain is indicated by 0 while the most severe pain is indicated by 10 In this method it is explained to the individual that there are two endpoints and that heshe is free to mark any point that defines hisher pain
The VAS was applied to the participants in the control group three times in the latent 3-4 cm active 5-7 cm and transition phases 8-10 cm of labour The VAS was also applied to those in the experimental group two times before and after the massage in each phase The diagnosis was made in accordance with the subjective data including the patients verbal expression
5 State-Trait Anxiety Inventory STAI FORM TX-I To determine state and trait anxiety levels of the participants the state-trait anxiety inventory STAI FORM TX -I was used The individual is required to indicate the feelings or behaviours that heshe has experienced in a specific situation according to the degree of severity by marking one of the options such as 1 Never 2 Little 3 Very and 4 Completely The state-trait anxiety inventory requires the individual to describe how heshe feels at a certain moment and under certain conditions by considering hisher feelings about a specific situation While high scores indicate high anxiety levels low scores indicate low anxiety levels The state-trait anxiety inventory consists of 20 statements The score obtained from the scale may vary between 20 and 80 While a high score represents a high anxiety level a low score represents a low anxiety level In the scoring performed in accordance with the criteria directive 0-19 points are regarded as none 20-39 points are regarded as mild anxiety 40-59 points are regarded as moderate anxiety 60-79 points are regarded as heavy anxiety and 80 points are regarded as severe anxiety In our study the STAI FORM TX-I was used in the active 5-7 cm phase in the control group and in the active 5-7 cm phase after the massage in the experimental group to evaluate the anxiety experienced by women during labour
Data Collection
After approval and permission to conduct the study were obtained from the ethics committee the hospitals head nurse delivery room charge nursemidwife and other midwives and nurses were interviewed and informed about the purpose and scope of the study Data were collected by one of the researchers The researcher was aware of which patients were assigned to each group However the researchers did not interfere in any way with the study results When they encountered women who met the inclusion criteria of the study the purpose of the study was explained and written consents were received from those who agreed to participate in the study For the women who satisfied the criteria participation in the study was voluntary Additionally during the study no women requested to withdraw and no women were excluded from the study Routine care and treatments for the women continued during data collection
Procedure
Before the research data were collected an informative meeting regarding the purpose and scope of the study was held for the members of the healthcare team who worked in the obstetrics and gynaecology clinic of the Turkish Republic Ministry of Health Public Hospitals Administration of Turkey at the Istanbul Province xxx Training and Research Hospital where the study would be conducted In addition cooperation was provided by the members of the healthcare team For the correct application of the massage the researcher was trained by the physical therapist who work at hospital The massage was applied only to the pregnant women in the intervention group at every phase of labour There was no intervention in the control group except for routine hospital applications The steps taken in this study are discussed below
For the pregnant women included in the experimental group
One-on-one interviews were conducted with the pregnant women and the voluntary disclosure forms which explained the purpose of the study were completed
The prepared questionnaire form was applied
In addition to providing them with routine nursingmidwifery care the women in the experimental group were administered a massage to the sacral region under the supervision of a doctor for 30 minutes using the effleurage patting 15 minutes and vibration technique 15 minutes in the latent 3-4 cm active 5-7 cm and transition 8-10 cm phases of labour To achieve this the patients were placed in the left lateral position in the latent 3-4 cm active 5-7 cm and transition 8-10 cm phases of labour
The state-trait anxiety inventory STAI FORM TX-I was applied and evaluated after the massage in the active 5-7 cm phase
The Visual Analogue Scale VAS was evaluated once after the massage in the latent 3-4 cm active 5-7 cm and transition 8-10 cm phases
Birth action follow-up form and postpartum interview forms were applied
For the pregnant women included in the control group
One-on-one interviews were conducted with the pregnant women and the voluntary disclosure forms which explained the purpose of the study were completed
The prepared questionnaire form was applied
Routine nursingmidwifery care was applied
The state-trait anxiety inventory STAI FORM TX-I was applied and evaluated in the active 5-7 cm phase
The Visual Analogue Scale VAS was evaluated once in the latent 3-4 cm active 5-7 cm and transition 8-10 cm phases
Birth action follow-up form and postpartum interview forms were applied One-on-one interviews were conducted with the women in both groups and the voluntary disclosure forms which explained the purpose of the study were completed After the prepared questionnaire form was applied to the women in the experimental group routine nursingmidwifery care was provided
Data analysis
In the evaluation of the data in addition to descriptive statistical methods eg percentage frequency mean and standard deviation the chi-square test and Students t-test were used in the comparison of the qualitative data The results were evaluated at a significance level of p 005
The dependent variables of the study are the pain score averages of the pregnant women the duration of the latent active and transition phases of labour and the anxiety level score The independent variables of the study are the pregnant womens age educational status working status and prenatal educational status as well as the educational status of the husbands of the pregnant women their willingness to become pregnant and the willingness to serve as controls before labour
This was a randomized and controlled experimental study aimed to determine the effects of sacral massage on labour pain and anxiety
Setting and samples
The study was performed in volunteer pregnant women who applied to xxx Training and Research Hospital Delivery Unit to undergo their first labour between January 25 and October 25 2016 This unit contains 1 delivery room with 2 tables 2 labour follow-up rooms with 5 beds 1 postpartum room with 5 beds and 1 nursing room
According to hospital records in all 342 pregnant women who applied to xxx Training and Research Hospital Delivery Unit to undergo their first labour between January 25 and October 25 2016 constituted the population of the study The following inclusion criteria were used to determine participation in the study 1 19-40-year-old primiparous pregnant women2 Singleton pregnancies between 38-42 weeks 3 Pregnant women whose labour began spontaneously 4 Pregnant women with a healthy foetus 5 Pregnant women without any complications that may cause dystocia during labour 6 Pregnant women for whom analgesia and anaesthesia were not used during the first phase of labour 7 Pregnant women who volunteered to participate in the research and who could establish verbal communication In addition Pregnant women with high-risk pregnancies with caesarean section indication and Pregnant women with a chronic illness were excluded
The sample size was calculated by Medical Faculty Biostatistics Department using Minitab Program The sample volume to represent the population was determined as minimum 30 people for each group when considering comparison results of mean scores in the study of Field with a risk of α 005 an accuracy rate of 1-α 095 and a power ratio of B 020 1-B 080
The study was conducted with two groups namely Massage Group experimental and Control Group 30 pregnant women were included in each group therefore the study was conducted with a total of 60 pregnant women The women who participated in the study were randomized randomly as control double and experimental single groups according to the single or double patient admission numbers The women who participated in the study were randomized into either the control double or the experimental single group according to single or double patient admission numbers
Measurements
In this study the Questionnaire form Birth action follow-up form postpartum interview form Visual analogue scale VAS and State-trait anxiety inventory STAI FORM TX-I were used to collect the data
1 Questionnaire Form Questions that reflect the sociodemographic characteristics of the patients age educational status social security marital status information about pregnancy drugs used status of their willingness to become pregnant gestational week status of attending examinations status of collecting information about labour the methods used to cope with the pain and open-ended questions that evaluate the previous use of massage
2 Birth Action Follow-Up Form The questions that indicate the length of the first phase the interventions performed to shorten the first phase of labour the methods used by the patient to cope with the labour pain the emotional behaviours of the pregnant women during labour the length of the second phase adjustment of the pregnant women the presence of intervention in labour the status of episiotomy the total duration of labour and the babys health
3 Postpartum Interview Form Open and closed questions that indicate the pregnant womens thoughts about labour the status of overall satisfaction with labour and how the women feel were included in this form which was prepared by a researcher in accordance with the relevant literature
4 Visual Analogue Scale VAS The Visual Analogue Scale VAS was used to measure the severity of labour pain On this scale numbers from 0 to 10 appear on a horizontal line of 100 mm The pain level is expressed in figures that range from 0 to 10 as follows the absence of pain is indicated by 0 while the most severe pain is indicated by 10 In this method it is explained to the individual that there are two endpoints and that heshe is free to mark any point that defines hisher pain
The VAS was applied to the participants in the control group three times in the latent 3-4 cm active 5-7 cm and transition phases 8-10 cm of labour The VAS was also applied to those in the experimental group two times before and after the massage in each phase The diagnosis was made in accordance with the subjective data including the patients verbal expression
5 State-Trait Anxiety Inventory STAI FORM TX-I To determine state and trait anxiety levels of the participants the state-trait anxiety inventory STAI FORM TX -I was used The individual is required to indicate the feelings or behaviours that heshe has experienced in a specific situation according to the degree of severity by marking one of the options such as 1 Never 2 Little 3 Very and 4 Completely The state-trait anxiety inventory requires the individual to describe how heshe feels at a certain moment and under certain conditions by considering hisher feelings about a specific situation While high scores indicate high anxiety levels low scores indicate low anxiety levels The state-trait anxiety inventory consists of 20 statements The score obtained from the scale may vary between 20 and 80 While a high score represents a high anxiety level a low score represents a low anxiety level In the scoring performed in accordance with the criteria directive 0-19 points are regarded as none 20-39 points are regarded as mild anxiety 40-59 points are regarded as moderate anxiety 60-79 points are regarded as heavy anxiety and 80 points are regarded as severe anxiety In our study the STAI FORM TX-I was used in the active 5-7 cm phase in the control group and in the active 5-7 cm phase after the massage in the experimental group to evaluate the anxiety experienced by women during labour
Data Collection
After approval and permission to conduct the study were obtained from the ethics committee the hospitals head nurse delivery room charge nursemidwife and other midwives and nurses were interviewed and informed about the purpose and scope of the study Data were collected by one of the researchers The researcher was aware of which patients were assigned to each group However the researchers did not interfere in any way with the study results When they encountered women who met the inclusion criteria of the study the purpose of the study was explained and written consents were received from those who agreed to participate in the study For the women who satisfied the criteria participation in the study was voluntary Additionally during the study no women requested to withdraw and no women were excluded from the study Routine care and treatments for the women continued during data collection
Procedure
Before the research data were collected an informative meeting regarding the purpose and scope of the study was held for the members of the healthcare team who worked in the obstetrics and gynaecology clinic of the Turkish Republic Ministry of Health Public Hospitals Administration of Turkey at the Istanbul Province xxx Training and Research Hospital where the study would be conducted In addition cooperation was provided by the members of the healthcare team For the correct application of the massage the researcher was trained by the physical therapist who work at hospital The massage was applied only to the pregnant women in the intervention group at every phase of labour There was no intervention in the control group except for routine hospital applications The steps taken in this study are discussed below
For the pregnant women included in the experimental group
One-on-one interviews were conducted with the pregnant women and the voluntary disclosure forms which explained the purpose of the study were completed
The prepared questionnaire form was applied
In addition to providing them with routine nursingmidwifery care the women in the experimental group were administered a massage to the sacral region under the supervision of a doctor for 30 minutes using the effleurage patting 15 minutes and vibration technique 15 minutes in the latent 3-4 cm active 5-7 cm and transition 8-10 cm phases of labour To achieve this the patients were placed in the left lateral position in the latent 3-4 cm active 5-7 cm and transition 8-10 cm phases of labour
The state-trait anxiety inventory STAI FORM TX-I was applied and evaluated after the massage in the active 5-7 cm phase
The Visual Analogue Scale VAS was evaluated once after the massage in the latent 3-4 cm active 5-7 cm and transition 8-10 cm phases
Birth action follow-up form and postpartum interview forms were applied
For the pregnant women included in the control group
One-on-one interviews were conducted with the pregnant women and the voluntary disclosure forms which explained the purpose of the study were completed
The prepared questionnaire form was applied
Routine nursingmidwifery care was applied
The state-trait anxiety inventory STAI FORM TX-I was applied and evaluated in the active 5-7 cm phase
The Visual Analogue Scale VAS was evaluated once in the latent 3-4 cm active 5-7 cm and transition 8-10 cm phases
Birth action follow-up form and postpartum interview forms were applied One-on-one interviews were conducted with the women in both groups and the voluntary disclosure forms which explained the purpose of the study were completed After the prepared questionnaire form was applied to the women in the experimental group routine nursingmidwifery care was provided
Data analysis
In the evaluation of the data in addition to descriptive statistical methods eg percentage frequency mean and standard deviation the chi-square test and Students t-test were used in the comparison of the qualitative data The results were evaluated at a significance level of p 005
The dependent variables of the study are the pain score averages of the pregnant women the duration of the latent active and transition phases of labour and the anxiety level score The independent variables of the study are the pregnant womens age educational status working status and prenatal educational status as well as the educational status of the husbands of the pregnant women their willingness to become pregnant and the willingness to serve as controls before labour
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None